ITN Magazine by tomyumkung

The Technology Solutions Resource for Medical Imaging & Radiation Oncology Professionals | www.itnonline.com | September 2016

Proton Therapyâ&#x20AC;&#x2122;s Explosive Sales Growth Advanced Molecular Imaging | 20 3-D Digital Breast Tomosynthesis | 32 COMPARISON CHARTS

Proton Therapy Systems | 16 Radiation Dose Management | 25 Scranton Gillette Communications

American Society for Radiation Oncology (ASTRO) | September 25-28 | Boston, Mass.

contents itnonline.com Quick, User-Friendly Access to Information 24/7 Read about new imaging technology hitting the market, plus new FDAcleared products on ITN’s responsive website — this and more news, updated daily. Highlights include:

• Comparison Charts Detailed speciﬁcations for dozens of products from major manufacturers, including recent charts on mobile C-arms and treatment planning systems.

RADIATION ONCOLOGY

A new ﬁeld of cardio-oncology is rapidly growing to help ﬁght the second leading cause of death among cancer patients.

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• New Technology Product introductions, works-inprogress and FDA clearances, plus an extensive database of products and services.

• Blogs Opinions and commentary from ITN editors and industry consultants, including Greg Freiherr discussing The Internet of Things.

• Information Channels Dedicated channels on key segments of interest, including women’s healthcare, IT, radiation oncology and molecular imaging.

• Buyer’s Guide A comprehensive vendor database with complete contact information for hundreds of companies.

• Current and Back Issues of ITN

| Proton Therapy Systems Comparison Chart

| Radiation Oncology Products

IMAGING

PHOTO COURTESY OF EPSILON

| Advanced Molecular Imaging Advanced imaging and hybrid modalities are evolving to aid and personalize future patient care.

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• Video Center Our enhanced viewer makes it easy to browse and view any of our 100+ itnTV videos, including newly posted videos from the show ﬂoor of the recent AAPM and AHRA annual meetings (to check it out, go to www.itnonline.com/videos).

| Assessing Cardiotoxicity Due to Cancer Therapy

| Imaging Technology Products | Radiation Dose Management Comparison Chart

INFORMATION TECHNOLOGY

| Three Beneﬁts of EMR Imaging Integration EMR integrations are key to simplifying operations and streamlining workﬂow with existing systems.

PHOTO COURTESY OF VITAL IMAGES

BUSINESS

| CDS as a Trusted Resource How intelligent clinical decision support reduces medical errors and drives value.

WOMENS’ HEALTHCARE

| 3-D Digital Breast Tomosynthesis: Still Going Strong The DBT market continues to thrive as facilities update older systems with this technology.

DEPARTMENTS

4 5 6 34

| From Your Editor by Melinda Taschetta-Millane | News Briefs | ASTRO Show Products Preview | The Last Read by Greg Freiherr

SPONSORED CASE STUDIES 14 19

| CyberKnife Provides Alternative for Lung Cancer Patients | Robust Treatment Planning at Europe’s First ProteusOne Center

PHOTO COURTESY OF CARESTREAM

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About the cover IBA’s ProteusOne emphasizes personalized comfort and accessibility while delivering a clinically advanced form of proton radiation therapy, and oﬀers pencil beam scanning, which minimizes radiation exposure to healthy tissue. PHOTO COURTESY OF IBA ION BEAM APPLICATIONS SA Imaging Technology News | itnonline.com | September 2016

from your editor

September 2016 | Vol. 55, No. 7

Melinda Taschetta-Millane

Leading Change in Imaging Informatics

he recent 2016 annual meeting of the Society for Imaging Informatics in Medicine (SIIM) in Portland, Ore., featured many key topics pertinent to this industry’s future growth. While there, I had the opportunity to discuss several of these issues with top industry leaders.

The society welcomed its new board chair, Paul G. Nagy, Ph.D., CIIP, FSIIM. He is associate professor at Johns Hopkins University School of Medicine and co-director of the Johns Hopkins Medicine Technology Innovation Center in Baltimore, Md. Nagy has been an incredibly important and prolific force in medical imaging informatics and within SIIM. I had the opportunity to discuss the main challenges to adaptive change in healthcare IT, and the adaptive leadership skills necessary to complement technological changes in a clinical setting with him at SIIM 2016. He also discussed his vision for SIIM as he assumes leadership as incoming chair. You can watch the video at http://bit.ly/2adKJdp. itnTV caught up with opening keynote speaker and SIIM treasurer Rasu B. Shrestha, M.D., MBA, chief innovation officer, University of Pittsburgh Medical Center and executive vice president, UPMC Enterprises, to discuss the dynamic changes that imaging is facing today. You can hear his viewpoints at http://bit.ly/29L6bSN. This marked the third year for the SIIM Hackathon. itnTV sat down with Marc D. Kohli, M.D., Hackathon Committee co-chair, SIIM Board of Directors and director of clinical informatics at UCSF, to discuss some of its new objectives and future plans. At this year’s Hackathon, attendees were able to see teams of coders, CIIPs, physicians and IT professionals working together to solve healthcare’s current problems and to shape a better future using the new, Web-based Health IT standards of SIIM’s SWIM, HL7, FHIR and DICOMweb. Check out the video at http://bit.ly/29SL0hb. The 2016 Dwyer Lecture, “Peering into the Future Through the Looking Glass of Artificial Intelligence,” was presented by Eliot L. Siegel, M.D., FSIIM July 1 at the closing session of the

meeting. Siegel is professor and vice chairman of imaging information systems, University of Maryland School of Medicine; chief of imaging, VA Maryland Health Care System. During the conference, we had the opportunity to talk with him about the current state of the industry in computer-aided detection and diagnosis. You can hear Siegel’s views at http://bit.ly/29L6vAP. New this year is the SIIM Innovation Challenge, which offered a prize of $10,000 to the winning team to help support innovation, exploration and development to raise awareness and engagement in innovation efforts that will help shape the present and future of imaging informatics. Co-chairs Ram Chadalavada, M.D., MS, CIIP and Adam Kaye, M.D., MBA, CIIP, discussed some of the innovative ideas presented at this year’s challenge, and future plans, with itnTV at http://bit.ly/2a5Hwvh. During the SIIM 2016 general closing session, the winner of the prize was announced and awarded to James J. Morrison, M.D., interventional radiologist and clinical informatics fellow from Oregon Health and Science University (OHSU) for his project, Voice Enabling the Image Enterprise. Morrison and his OHSU team — Jonathan Steinberger, M.D., Steven Kassakian, M.D., and Eric Leung, Ph.D. candidate — were one of four finalists who demonstrated their projects in the Science and Innovation Pavilion throughout the annual meeting, and then gave final pitch presentations to a panel of judges representing the fields of clinical medicine, informatics, business and finance. Be sure to mark your calendars for the SIIM 2017 annual meeting, June 1-3 in Pittsburgh.

mtaschetta-millane@sgcmail.com

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We welcome your comments on the topics found in Imaging Technology News. Please send your thoughts to mtaschetta-millane@sgcmail.com 4

September 2016 | itnonline.com | Imaging Technology News

3030 W. Salt Creek Lane, Suite 201 Arlington Heights, IL 60005 Telephone: 847.391.1000 Fax: 847.390.0408 Editorial Editorial Director Melinda Taschetta-Millane | mtaschetta-millane@sgcmail.com 847.954.7961 Editor Dave Fornell | dfornell@sgcmail.com Associate Editor Jeff Zagoudis Advertising Sales Publisher Sean Reilly | sreilly@sgcmail.com 847.954.7960, Fax: 847.390.0408 Integrated Media Consultant (West/Midwest) Stephanie A. Ellis | sellis@sgcmail.com 847.954.7959, Fax: 847.390.0408 Integrated Media Consultant (East/Southeast) Louise Clemens | lclemens@sgcmail.com 216.342.4012, Fax: 847.390.0408 Advertising Coordinator Karen Teeter | kteeter@sgcmail.com Marketing and Creative Services Marketing Director Michael Porcaro | mporcaro@sgcmail.com Creative Services Assistant Manager Holly Dryden | hdryden@sgcmail.com Designer Dan Soltis | dsoltis@sgcmail.com Circulation Director Audience Development Doug Riemer | driemer@sgcmail.com Questions about your subscription/How to reach circulation: Senior Audience Development Manager Donna Heuberger | dheuberger@sgcmail.com 847.954.7986 For list rental information, contact Geffrey Gardner at 845.201.5331; geffrey.gardner@reachmarketing.com. Corporate Karla A. Gillette | Chairperson Edward Gillette | President, CEO Ann O’Neill | Senior Vice President David Shreiner | Senior Vice President, CFO Kevin Herda | Vice President, Information Technology Diane Vojcanin | Vice President, Content and Custom Media Halbert S. Gillette | Chairman Emeritus (1922-2003) www.scrantongillette.com Editorial Advisory Board Paul J. Chang, M.D. | Prof. and Vice-Chairman Radiology Informatics, Medical Director of Pathology Informatics, University of Chicago, Pritzker School of Medicine; Medical Director of Enterprise Imaging, University of Chicago Hospitals Greg Rose, M.D., Ph.D. | Radiologist, CEO, Rays Katherine Andriole, Ph.D. | Center for Evidence-Based Imaging in the Department of Radiology at Brigham and Women’s Hospital Edward M. Smith, Sc.D., FACNP | Professor of Imaging Sciences University of Rochester Medical Center Sam Friedman, M.D. | Nuclear Radiologist, Chief Technology Officer Pitts Radiology, S.C. Carter Newton, M.D., FACC | Asst. Prof. of Radiology, Asst. Clinical Prof. of Cardiology, University of Arizona, Tucson Vivek Mehta, M.D. | Radiation Oncologist, Director, Center for Advanced Targeted Radiotherapies, Swedish Cancer Institute, Seattle, Wash. Contributors Kirill Shalyaev, Ph.D. | Philips Healthcare Molecular Imaging Erin Martin | RamSoft Inc. Ami Mayo, M.D. | medCPU Rachael Bennett | MD Buyline Julie Johnson | MD Buyline ITN (Imaging Technology News) (ISSN 0361-4174) is published in Jan, Mar, Apr, May, June, July, Sept, Oct and Nov (9 times per year) by Scranton Gillette Communications , 3030 W. Salt Creek Lane, Arlington Heights, IL 60005. Copyright 2016. Periodical Postage Paid at Arlington Heights, IL 60005 and additional mailing offices. Subscription Rates per year: USA and possessions $90, Canada $120 per year, all other countries $150 per year (includes air mail). Single Copy $15. ITN (Imaging Technology News) is mailed to physicians, clinicians, researchers, medical faculty and hospital staff active in diagnosis, clinical analysis, treatment, therapy and biomedical research. Available to others as follows: United States and possessions $90 per year, Canada $120 per year and all other countries $150 includes air-mail per year. Single copy $15. ITN (Imaging Technology News) accepts no responsibility or liability for the validity of information supplied by contributors, vendors, advertisers or advertising agencies. Scranton Gillette Communications, as publisher of ITN (Imaging Technology News), is not engaged in providing any specific medical advice, diagnosis or opinions on any medical symptom or condition. Permission to photocopy editorial content is granted only for the “private personal use” of the subscriber. Copying for any other use is expressly prohibited. Reprints/e-prints are available; contact 847.391.1036. Reprints produced by anyone other than Scranton Gillette Communications are not authorized. Printed in the USA. © Copyright 2016. Postmaster: Send address changes to Imaging Technology News, 3030 W. Salt Creek Lane, Suite 201, Arlington Heights, IL 60005-5025

News Athletes May Have White Matter Brain Changes Six Months After a Concussion

ew research ﬁnds white matter changes in the brains of athletes six months after a concussion. The study was presented at the Sports Concussion Conference in Chicago, hosted by the American Academy of Neurology, in July. The study involved 17 high school and college football players who experienced a sports-related concussion. The participants underwent magnetic resonance imaging (MRI) brain scans and were assessed for concussion symptoms, balance problems, and cognitive impairment, or memory and thinking problems, at 24 hours, eight days and six months following the concussion. Researchers also assessed 18 carefully matched athletes who had not experienced a concussion.

At all time points, all participants had advanced brain scans called diffusion tensor imaging and diffusion kurtosis tensor imaging to look for acute and chronic changes to the brain’s white matter. The scans are based on the movement of water molecules in brain tissue and measure microstructural changes in white matter, which connects different brain regions. Those who had concussions had less water movement, or diffusion, in the acute stages following concussion (24 hours, six days) compared to those who did not have concussions. These microstructural changes still persisted six months after the injury. Also, those who had more severe symptoms at the time of the concussion were more likely to have alterations in the brain’s white matter six months later.

Huge Helium Discovery Safeguards Future Supply for MRI

elium is essential for many modern technologies, including magnetic resonance imaging (MRI) scanners. Now, researchers have developed systematic search methods to discover one of the world’s biggest helium gas fields, associated with volcanoes in the Tanzanian Rift Valley in Africa. This is the first time that helium has been found intentionally — previous finds were by accident — and opens the way for further large finds. This work was reported at the Goldschmidt conference in Yokohama, Japan. Recent years have seen worries about the over-exploitation of this extremely limited, finite, valuable natural resource, with fears that supply could not be guaranteed into the medium to long-term future. In 2015, the British Medical Association expressed concern that helium supplies may have to be regulated. Now a team from Oxford and Durham universities, jointly led by Chris Ballentine and Jon Gluyas, has worked together with a helium exploration company, Helium One Ltd., to help uncover a huge helium resource in Tanzania. The team applied methodologies used in oil exploration in their search for helium. Normally oil exploration takes into consideration a range of factors, such as the rocks sourcing the oil, and how the oil is released into underground reservoirs. Crucially, the team found that being close to a volcano may be key, as the volcanic activity acts as the releasing mechanism for helium gas. While developing the technique in 2015, members of the same research group postulated significant helium resources in the Rocky Mountains.

Despite those ﬁndings, there was no diﬀerence between the group of athletes with and without concussion with regard to self-reported concussion symptoms, cognition or balance at six months post-injury. The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health, the U.S. Army Medical Research and Materiel Command and the NFL-GE Head Health Challenge I.

New Clues About the Aging Brain

European study led by Umeå University (Sweden) Professor Lars Nyberg has shown that the dopamine D2 receptor is linked to the long-term episodic memory, which function often reduces with age and due to dementia. This new insight can contribute to the understanding of why some but not others are affected by memory impairment. The results have been published in the journal PNAS. Using brain-imaging technologies (PET and MRI), memory tests and statistical analyses, Nyberg and his colleagues are trying to capture what happens to our memory and our brain as we grow old. The neurotransmitter dopamine is of significance to our motor functions but also to memory and other cognitive functions. The D1 receptor system has been linked to functions mediated by the frontal lobe, but it has been unknown what specific role the D2 receptor system has. In this study, a PET camera was used to examine individual differences in the D2 system in a vast group consisting of 181 healthy individuals between the ages of 64 and 68. All participants also had to take part in an all-inclusive performance test of the longterm episodic memory, working memory and processing speed along with an MRI assessment (which was used to measure the size of various parts of the brain). Researchers could see that the D2 system was positively linked to episodic memory, but not to working memory or to processing speed by relating PET registrations to the cognitive data. Researchers could also see that the D2 system affects the functioning of the hippocampus in the brain. The hippocampus is long linked to long-term episodic memory.

Briefs • ASTRO Gold Medal Awards Three leaders in radiation oncology, including clinicians and researchers from Duke University, Massachusetts General Hospital and Cedars-Sinai Medical Center, have been named recipients of the American Society for Radiation Oncology (ASTRO) Gold Medal, the highest honor bestowed upon members of the world’s largest radiation oncology society. ASTRO awards its annual Gold Medal to individuals who have made outstanding lifetime contributions in the field of radiation oncology, including achievements in clinical patient care, research, teaching and service to the profession. Benedick A. Fraass, Ph.D., FASTRO, Christopher G. Willett, M.D., FASTRO, and Anthony L. Zietman, M.D., FASTRO, will be recognized at an awards ceremony during ASTRO’s 58th annual meeting this month. In other news, ASTRO members have elected five new officers to the society’s board of directors. The new board of directors members are: president-elect Paul M. Harari, M.D., FASTRO, University of Wisconsin, Madison, Wis.; secretary/ treasurer-elect Geraldine M. Jacobson, M.D., MBA, M.Ph., FASTRO, West Virginia University, Morgantown, W.Va.; clinical affairs and quality council vice-chair Todd Pawlicki, Ph.D., FASTRO, University of California San Diego, San Diego; education council vice-chair Lynn D. Wilson, M.D., M.Ph., FASTRO, Yale University, New Haven, Conn.; and government relations council vice-chair Ronald D. Ennis, M.D., Mount Sinai West Hospital, New York.

• Ziehm Names Product Education and Development Director Ronald Villane has been appointed product education and development director for Ziehm Imaging. Villane has worked for Ziehm for more than 14 years, having most recently served as a product support engineer.

Ron Villane

• SIIM Recognizes Leaders The Society for Imaging Informatics in Medicine (SIIM) welcomed a new board chair, Paul G. Nagy, M.D., at its 2016 annual meeting. Nagy is associate professor at Johns Hopkins University School of Medicine and co-director of the Johns Hopkins Medicine Technology Innovation Center in Baltimore. Nagy has been an important and prolific force in medical imaging informatics and within SIIM. His diverse roles as mentor to a whole generation of imaging informatics experts, and as innovative medical physicist, trail blazing medical imaging informatician, management expert, quality expert and software developer are without parallel in medicine. In addition, honors were awarded to David A Clunie, MBBS, with his induction into the SIIM College of Fellows. Clunie, an outstanding innovator and critical thinker, has been a highly effective developer and promoter of open standards throughout his career. The 2016 Dwyer Lecture, “Peering into the Future Through the Looking Glass of Artificial Intelligence” was presented by Eliot L. Siegel, M.D., FSIIM. Siegel is professor and vice chairman of imaging information systems, University of Maryland School of Medicine; and chief of imaging, VA Maryland Health Care System.

Imaging Technology News | itnonline.com | September 2016

ASTRO Show Preview | PRODUCTS |

Enhancing Value, Improving Outcomes The American Society for Radiation Oncology’s (ASTRO) 58th annual meeting will be held Sept. 25-28, 2016, at the Boston Convention and Exhibition Center. This scientiﬁc meeting in radiation oncology attracts more than 11,000 oncologists from all disciplines and from around the world. Highlights include the latest ground-breaking science presented at the plenary and clinical trials sessions, a full program of education sessions, panels and workshops covering all disease states and tracks, and a full exhibit hall. Some of the products being featured are listed below. For more information: www.astro.org

Imaging Server

Advanced Treatment Planning Monaco is Elekta’s advanced treatment planning solution that combines powerful Monte Carlo accuracy and multicriterial optimization to support the spectrum of radiotherapy techniques, including advanced 3-D, IMRT, VMAT and dynamically constrained stereotactic — all in a single system. Users can be conﬁdent that the dose planned is the dose delivered, enhanced with Monaco 5.11 providing optimization and speed enhancements. In addition, while Monaco is an open system, it takes advantage of Elekta’s Versa HD system to deliver dynamic radiosurgery. Elekta | www.elekta.com

Clinical Intelligence Platform The Velocity platform from Varian Medical Systems was developed by oncologists to overcome a fundamental obstacle to quality care — the proliferation of disconnected silos of patient information. Velocity’s leading clinical intelligence platform integrates all imaging and treatment information into a comprehensive and powerful dashboard, transforming unconnected data into actionable clinical knowledge. Velocity enables clinical decision support, operational eﬃciency, collaboration and more.

MIM Software will demonstrate MIM Assistant, providing data storage, automatic querying for diagnostic images, and automatic routing and fetching protocols, at the ASTRO annual meeting. With MIM Assistant, users can create a rule-based environment to automatically process incoming patient data and run MIM workﬂows. Examples include auto-contouring a CT and saving the structures to the patient list, or fusing images for review as soon as they arrive at the workstation. MIM Software | www.mimsoftware.com

Varian Medical Systems | www.varian.com

Dosimetrically Matched Universal Couchtops Civco’s Universal Couchtop Long Extension offers DoseMatch Technology, which creates clean and easy treatment planning and imaging due to a large, junction- and artifact-free treatment area. Universal Couchtop is optimized for use with Civco’s comprehensive motion management solutions, seamlessly connecting patient imaging and treatment while providing efficient workflow and performance. Civco Radiotherapy | www.civcort.com

Adaptive Treatment Planning RayStation combines all the tools you need for adaptive planning in a single system. The dose tracking feature shows exactly where your dose is going so you can re-plan as needed, and powerful automation makes the process fast and practical. RayStation 5 also includes Plan Explorer, an automated tool that rapidly computes plans for speciﬁed treatment approaches and equipment setups. The company will also oﬀer a preview of the upcoming innovations in RayStation 6. RaySearch Laboratories | www.raysearchlabs.com

QA Phantom The new CIRS SRS Multi-Lesion QA Phantom, Model 037, provides a fast, comprehensive solution for QA of single isocenter plans treating multiple targets simultaneously. The phantom allows for thorough validation of multilesion treatment methods and patient-speciﬁc quality assurance using radiochromic ﬁlm. Linear attenuation of the brain-equivalent phantom is within 1 percent of real tissue from 50 keV to 15 MeV. CIRS | www.cirsinc.com

September 2016 | itnonline.com | Imaging Technology News

DISCOVER YOUR ONCOPEER CLOUD COMMUNITY

SHARE. CONNECT. LEARN. The OncoPeer™ cloud community is an easy, secure way for oncology professionals to collaborate and share data. Participate in dynamic discussions, exchange advice and best practices, and expand your professional network—while working together in the ﬁght against cancer. Join the OncoPeer cloud community at oncopeer.com Sponsored by Varian © 2015, 2016 Varian Medical Systems, Inc. Varian and Varian Medical Systems are registered trademarks, and OncoPeer is a trademark of Varian Medical Systems, Inc.

ASTRO Show Preview See the full picture at raysearchlabs.com

Electronic Brachytherapy System iCAD’s Xoft Axxent Electronic Brachytherapy (eBx) System oﬀers signiﬁcant treatment time, mobility and cost advantages. Its proprietary miniature X-ray source delivers high dose rate, low energy radiation, which targets cancer cells and minimizes exposure to healthy tissue with minimal shielding requirements. It is FDAcleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, gynecological cancers and nonmelanoma skin cancer. iCAD | www.icadmed.com

Open Bore MRI Package

booth t a s u Visit RO and T S A t n 2a #1201 emonstratio get a d

The Magnetom RT Pro Edition from Siemens Healthineers is a comprehensive package for radiation therapy professionals that includes a 70 cm open bore scanner (either the Magnetom Aera 1.5T or the Magnetom Skyra 3T MR system), optional Tim Dockable Table and high-channel ﬂex coils. The package also includes positioning accessories, dedicated MR applications, workﬂow protocols and optional post-processing software. Siemens Healthineers | www.usa.siemens.com

Tracking and Reporting System

GET ON TRACK WITH ADAPTIVE THERAPY Heading for adaptive? Getting underway is plain sailing with the dose tracking feature in RayStation. You’ll see exactly where your dose is going, so you can replan as needed, with powerful automation to speed up your navigation. Now you can be certain treatment delivery is on course to achieve your clinical goals.

MagView’s LungView is a comprehensive tracking and reporting system for lung screening programs. Flexible to fit into any workflow, LungView provides automated patient follow-up records, patient/ clinician notification and reminder letters, outcome statistics, pathology tracking, unlimited custom reports, integration with any RIS, HIS, EMR, PACS or VR vendor and optional results creation. MagView | www.lungview.com

RayStation – adaptive therapy is now.

Radiation Therapy Planning Discovery RT uses an all-encompassing approach to radiation therapy planning. Its streamlined workﬂow and sub-millimetric images are eﬀectively free of motion and metal artifacts. It allows virtually complete imaging of the entire bore so nothing is missed. Discovery RT is a comprehensive radiation therapy solution. GE Healthcare | www.gehealthcare.com 8

September 2016 | itnonline.com | Imaging Technology News

Treatment Delivery System Join Accuray at ASTRO booth #2009 on Sunday, Sept. 25, for the unveiling of the company’s newest innovations, the Radixact Treatment Delivery System, Accuray Precision Treatment Planning System and iDMS Data Management System. See demonstrations of smart solutions designed to help clinicians deliver precise tumor treatments with conﬁdence, and engage in peer-to-peer education intended to provide new information, insights and ideas for maximizing Accuray products. Accuray | www.accuray.com

Transmission Detector IBA released the Dolphin Online Ready transmission detector to enhance patient QA efficiency. The Dolphin ion chamber detector is set up in one minute to measure the patient’s treatment dose. Measurements are wirelessly transmitted and automatically verified and displayed with a traffic light solution. Further evaluations of the dose errors can be performed in 3-D patient anatomy TPS-class software. Dolphin is released for pre-treatment QA, its design is ready for online use pending linac manufacturer’s approval. IBA | www.iba-protontherapy.com

Patient-Friendly PET/CT System Toshiba’s Celesteion PET/CT system helps healthcare providers elevate the patient experience while combining high-performance PET and CT for all radiation and oncology imaging needs. Well-suited for procedures including tumor detection, treatment evaluation and CT simulation, the system prioritizes patient safety and comfort with a large bore, wide ﬁeld-of-view and time-of-ﬂight imaging. The Celesteion comes standard with Toshiba’s advanced CT dose reduction technology, AIDR 3D, and conforms to MITA’s XR-29 Smart Dose Standard requirements. Toshiba America | www.medical.toshiba.com

Dose Monitoring Standard Imaging, Inc. introduces Adaptivo, a new technology that utilizes the treatment machine’s portal imager and cone beam CT capabilities. Adaptivo will empower oncologists to make informed decisions whether to adapt treatment plans based on the dose a patient has accumulated during treatment. Adaptivo makes use of the portal imager to capture exit images during treatment, and accumulated dose to critical organs throughout the entire course of treatment can also be monitored. Standard Imaging | www.standardimaging.com Imaging Technology News | itnonline.com | September 2016

RADIATION ONOLOGY

Cardio-oncology

Assessing Cardiotoxicity

Due to Cancer Therapy A new Ƥeld of cardio-oncology is rapidly growing to help Ƥght the second leading cause of death among cancer patients

By Dave Fornell

ardio-oncology is an emerging ﬁeld that combines the expertise of both cardiology and oncology to assess and treat cancer patients for the second leading cause of death among cancer survivors — cardiovascular disease brought on by their treatments. Speciﬁc types of chemotherapy and chestdirected radiation therapy are known to cause cardiac dysfunction, mainly due to cardiotoxicity — the symptoms of which may not present until months or even years after cancer treatment.

Cancer treatments can lead to cardiovascular health problems, including increased risk of cardiac dysfunction, heart failure, arrhythmias, valvular heart disease, accelerated atherosclerosis and pericardial disease. Cardio-oncology as a ﬁeld includes both cardiology and oncology specialists working together across all aspects of cardiovascular risk determination, prevention and treatment, starting at cancer diagnosis and continuing throughout survivorship. The cardiac assessment of these patients centers on ultrasound to monitor myocardial or structural damage caused by cancer therapy. This new specialty area was the focus of several presentations at the American College of Cardiology (ACC) 2016 annual meeting. There are 14.5 million cancer survivors in the United States today, said Anecita Fadol, Ph.D., RN, FNP, FAANP, assistant professor, Department of Nursing, The University of Texas, MD Anderson Cancer Center, Houston, Texas, speaking at ACC.16. She explained the leading cause of death among these survivors is 51 percent mortality due to the cancer itself, but another 33 percent die due to cardiovascular disease that is often caused or exacerbated by the cancer treatment.

Cancer Therapy and Heart Damage Both chemotherapy and radiation therapy are largely based on the concept of slowly killing cancer cells through several treatment sessions. These are spaced out to allow healthy, normal cells in the body time to repair and recover before the next treatment. Cancer cells cannot recover or repair DNA damage as quickly, or as well, as normal cells. This leads to cancer cell death or leaves these cells too badly damaged to replicate.

cardiovascular toxicity. Doxorubicin has the most studies, so there is a large amount of data showing its clear impact on the myocardium. Radiation therapy also can lead to cardiovascular dysfunction, including valve and vascular disease. Fadol said this is often seen in women who undergo radiation treatments for breast cancer. She said the worst cardiovascular outcomes are seen in patients who undergo combined radiation and anthracycline treatments.1

“Cardio-oncology as a ﬁeld includes both cardiology and oncology specialists working together across all aspects of cardiovascular risk determination, prevention and treatment, starting at cancer diagnosis and continuing throughout survivorship.”

September 2016 | itnonline.com | Imaging Technology News

Fadol said numerous clinical studies have conﬁrmed anthracycline chemotherapy agents (including doxorubicin, epirubicin, idarubicin and mitoxantrone) are the primary cause of

Fadol said the onset of anthracycline-induced cardiotoxicity is usually seen several months after treatments begin, but there can be late onset up to a year or more after treatments ended. The injury

Epsilon’s EchoInsight software helps analyze cardiac function by evaluating wall motion strain.

Toshiba’s cardiac ultrasound wall motion tracking software helps quanitify myocardial strain to determine cardiotoxcity caused by cancer treatments.

includes permanent cell damage that can progress to uncompensated heart failure. However, she explained heart failure is not a death sentence for cancer patients, because today the condition can be managed with medication and implantable cardioverter deﬁbrillators (ICDs). This is an area where collaboration with cardiology is important, she stressed. Fadol said the biggest impact of cancer treatment cardiotoxicity is seen in children. “All survivors of childhood cancer are at increased risk of cardiotoxicity regardless of the therapy used,” she said. Anthracycline doses above 250 mg/m2 usually result in a higher incidence of cardiovascular dysfunction in children. With levels above 450 mg/m2, cardiovascular toxicity occurs, Fadol said. Other types of chemo agents can also impact the heart, said Eugene Storozynsky, M.D., Ph.D., University of Rochester Medical Center, Rochester, N.Y. An example of this is the monoclonal antibody agent trastuzumab, which interferes with the HER2/ neu receptor in breast cancer. He explained the agent inhibits the neuregulin-1 (NRG-1) pathways, which are essential for the activation of cardiomyocytes and the maintenance of cardiac function. The result is a reduction in contractile force that results in reduced ejection fractions. Risk factors involved in assessing patients include cumulative dose of chemo, age of patient at exposure, concomitant administration of other

Epsilon’s EchoInsight software is used to help evaluate cardiotoxcity due to chemotherapy or radiation therapy.

cardiotoxic drugs, and concurrent or prior radiation therapy, Fadol said.

Imaging to Monitor Cardiac Function Cardiac imaging surveillance of cancer patients can be done using echocardiography, nuclear imaging or magnetic resonance imaging (MRI), said Storozynsky. However, echo is the easiest modality for most patients and centers to access, and is less expensive than nuclear or MRI. He said 3-D echo allows the calculation of very accurate ejection fractions. Live tissue Doppler allows imaging of cardiac function by assessing wall motion, and this can be enhanced using echo contrast. One cardiac ultrasound innovation that is widely used to assess cancer patients’ hearts is echo strain imaging. This advanced visualization software allows simultaneous assessment of three diﬀerent views of the myocardium. The software allows quantiﬁcation of the amount of left ventricular (LV) systolic function muscle strain in each view. Storozynsky said strain imaging can show microscopic changes in movement of the myocardium prior to the presentation of symptoms. A recent echocardiographic study4 of 1,820 adult survivors of childhood cancer using 3-D LV ejection fraction (LVEF) and strain imaging found abnormal global longitudinal strain and diastolic function may

better identify subsets of survivors at higher risk for poor clinical cardiac outcomes who may benefit from early medical intervention. Only 5.8 percent of survivors had abnormal 3-D LVEFs of less than 50 percent. However, 32.1 percent of survivors with normal 3-D LVEFs had evidence of cardiac dysfunction by global longitudinal strain (28 percent). Abnormal global longitudinal strain was associated with patients who received chestdirected radiotherapy and an anthracycline dose of more than 300 mg/m2. The ongoing Strain surveillance during Chemotherapy for improving Cardiovascular Outcomes (SUCCOUR) Trial is the first large-scale, international randomized study of chemotherapy patients at risk of cardiotoxicity. The study includes 12 countries, including U.S. centers. Patients will undergo cardioprotection guided by measurement of LV strain, compared with cardioprotection guided by measurement of LV ejection fraction, for avoidance of cardiotoxicity. The trial began enrolling patients in 2014 and will follow them out to three years. Storozynsky said the results of that trial will definitively show whether strain is a better marker than ejection fraction for earlier detection of cardiotoxicity. He said another approach is to use multimodality imaging (echo and nuclear) starting at the onset of administration of chemotherapy. Follow-up exams Imaging Technology News | itnonline.com | September 2016

RADIATION ONOLOGY

Cardio-oncology

GE Healthcare’s cardiac ultrasound cardiac strain assessment software helps quantify left ventricular wall motion to determine if there is damage to cardiac function due to cancer therapy.

are then done after half of the cumulative dose has been administered and before every subsequent dose thereafter. After treatment is completed, follow-up imaging should take place at three, six and 12 months to assess ejection fraction. National Comprehensive Cancer Network (NCCN) guidelines for patients who receive anthracycline treatments call for screening for heart failure within one year of treatment. At MD Anderson, Fadol said patients usually get a baseline echo exam prior to treatments and are followed up with an echo after treatment is completed.

Patient Risk Assessment, Modification Most cancer patients who undergo chemotherapy get cardiomyopathy with some loss of LV function, said Joseph R. Carver, M.D., chief of staff and professor of medicine, Abramson Cancer Center of the University of Pennsylvania. He said heart failure is seen in between 1-5 percent of these patients. Radiation therapy further extends risk to all cardiac structures, not just the myocardium. Carver said this includes the conduction system, valves, endocardium and the myocardium. He said risk factors include radiation doses above 30 Gy per day, higher dose/fractions of 2 Gy per day and the field volume being treated. Those patients who do develop heart failure are usually in American College of Cardiology (ACC)/ American Heart Association (AHA) Stage B, for which Carver said there are guidelines to assess and treat them. “Cardio-oncologists can help oncologists make decisions about care and treatment,” Carver explained. He said primary prevention of cardiotoxicity can be accomplished via risk factor modifications. These include use of a non-anthracycline regimen, lower dosing, decreasing peak plasma concentration or use of “targeted” doxorubicin. Protective pharmacology might also be implemented, including use of dexrazoxane, which protects the heart against the cardiotoxic side effects of chemotherapeutic drugs, including anthracyclines. ACE/ARB beta-blockers, 12

September 2016 | itnonline.com | Imaging Technology News

statins and ACE inhibitors may also offer options to help protect the heart, Carver said. Another cardioprotective treatment option is the use of liposomal doxorubicin, which Carver said uses a lipid encapsulation of the chemo drug. This increases the size of the drug molecule, which prevents it from entering the heart, but it can still infiltrate tumors. An investigational chemo agent now in trials that may offer additional cardioprotection is zoptarelin doxorubicin, a so-called Trojan horse agent. It consists of doxorubicin linked to a small peptide agonist to the luteinizing hormone-releasing hormone (LHRH) receptor. These receptors are present in large numbers in endometrial, ovarian, prostate and breast cancers. Carver said the receptors allow targeted release of the doxorubicin mainly in cancer cells, instead of systemic use of the agent where it causes collateral damage to the heart.

Cardio-oncology Services Still Lacking A nationwide study conducted by the ACC and published in 2015 identified current frequent barriers to cardio-oncology services in the United States. According to the study, many hospital training programs have no formal training or services in cardio-oncology, and a lack of national guidelines and funding also creates barriers.5 Of the 106 respondents, more than 70 percent felt the cardiovascular implications of cancer treatments were a very important consideration in the cancer patient treatment continuum. Sixty-five percent thought access to consultants with specialized training would provide an advantage in caring for cancer patients suffering cardiovascular complications. However, only 35 percent of centers surveyed included cardio-oncology services in their pre-operative consultation services managed by general cardiology, and only 27 percent of centers had an established, specialized cardio-oncology service with multiple clinicians. Sixteen percent had a single cardiologist with expertise in treating cancer patients, and 12 percent had no cardio-oncology services but planned to add them within a year.

Almost half of respondents said their programs offered no formal training in cardio-oncology, with a majority of the other half offering exposure during regular rotations. For 44 percent of programs surveyed, the reason for no or limited training was both a lack of national guidelines in cardio-oncology and a lack of funding. But the need is there. A significant number of those surveyed reported they did not feel confident in dealing with cardiovascular care specific to cancer patients, and gave themselves only an average rating when asked about their level of understanding of the impact of holding or stopping cancer treatments on cancer outcomes. “Despite the common belief that cancer patients with treatment-related cardiovascular issues would greatly benefit from a specialized team devoted to the cardio-oncology field and a significant number of cancer patients experiencing treatment-related cardiovascular issues, we are lacking the proper resources to care for these patients,” said Ana Barac, M.D., Ph.D., lead author of the study and director of the cardio-oncology program at MedStar Heart and Vascular Institute in Washington, D.C. “A newly formed American College of Cardiology section dedicated to filling this gap will give physicians in the field a forum to discuss best practices and work together to develop methods for training more physicians in providing the best possible care for these unique patients.” itn References: 1. Armstrong, et al. Journal of Clinical Oncology 2013. 319290.3673-3680. 2. Swain SM, Whaley FS, Ewer MS, et al. “Congenital Heart Failure in Patients.” Cancer 2003. 97:2869-79. 3. Yeh ET, Bickford CL, et al. “Cardiovascular Complications of Cancer Therapy.” Journal of the American College of Cardiology 2009. 53:2231-47. 4. Gregory T. Armstrong, Vijaya M. Joshi, Kirsten Ness, et al. “Comprehensive Echocardiographic Detection of Treatment-Related Cardiac Dysfunction in Adult Survivors of Childhood Cancer — Results From the St. Jude Lifetime Cohort Study.” J Am Coll Cardiol. 2015;65(23):2511-2522. doi:10.1016/j.jacc.2015.04.013. 5. Ana Barac, Gillian Murtagh, Joseph Carver, et al. “Cardiovascular Health of Patients With Cancer and Cancer Survivors — A Roadmap to the Next Level.” J Am Coll Cardiol. 2015;65(25):2739-2746. doi:10.1016/j.jacc.2015.04.059.

The powerful combination of Versa HD™ and Monaco® delivers a unique blend of unrivaled dose delivery and intelligent dose planning. With the ultra-low transmission of Agility™ and Monaco’s Monte Carlo accuracy, dose delivery to the target can be precisely controlled while ensuring surrounding anatomy is protected. Together, they make dynamic and stereotactic techniques not only possible but routine practice. GO BEYOND with Versa HD and Monaco. LEARN MORE AT BOOTH 7017 DURING ASTRO 2016.

45133711439 Rev03.16

Solutions Applied | A CASE STUDY | Sponsored by Accuray

The CyberKnife System Provides an Alternative for Lung Cancer Patients Â&#x201D;Â&#x17D;Â&#x192;Â?Â&#x2030;Â&#x2021;Â&#x201D; Â&#x2021;Â&#x192;Â&#x17D;Â&#x2013;Â&#x160; Â&#x203A;Â&#x2022;Â&#x2013;Â&#x2021;Â?Â&#x2022; Â&#x2014;Â&#x2022;Â&#x2021;Â&#x2022; Â&#x203A;Â&#x201E;Â&#x2021;Â&#x201D; Â?Â&#x2039;Â&#x2C6;Â&#x2021; Â&#x203A;Â&#x2022;Â&#x2013;Â&#x2021;Â? Â&#x2013;Â&#x2018; Â&#x2019;Â&#x201D;Â&#x2018;Â&#x2DC;Â&#x2039;Â&#x2020;Â&#x2021; Ď?Â&#x2039;Â&#x2020;Â&#x2014;Â&#x2026;Â&#x2039;Â&#x192;Â&#x17D;ÇŚÂ&#x2C6;Â&#x201D;Â&#x2021;Â&#x2021; Â&#x2013;Â&#x201D;Â&#x2021;Â&#x192;Â&#x2013;Â?Â&#x2021;Â?Â&#x2013; Â&#x2C6;Â&#x2018;Â&#x201D; Â&#x2021;Â&#x192;Â&#x201D;Â&#x17D;Â&#x203A;ÇŚÂ&#x2022;Â&#x2013;Â&#x192;Â&#x2030;Â&#x2021; Â&#x17D;Â&#x2014;Â?Â&#x2030; Â&#x2026;Â&#x192;Â?Â&#x2026;Â&#x2021;Â&#x201D; Â&#x2019;Â&#x192;Â&#x2013;Â&#x2039;Â&#x2021;Â?Â&#x2013;Â&#x2022;

rlanger Health Systems in Chattanooga, Tenn., purchased a CyberKnife Robotic Radiosurgery System in December 2010 to develop a stereotactic body radiation therapy (SBRT) program in its Radiation Oncology Department. The CyberKnife System included the Lung Optimization Treatment (LOT) function, which provides fiducial-free SBRT of early-stage lung cancer patients. Once the CyberKnife System was in use, the clinical team at Erlanger collaborated with referring physicians to explain to thoracic surgeons and pulmonologists â&#x20AC;&#x201D; at Erlanger and other hospitals in the community â&#x20AC;&#x201D; how the system could be utilized as a treatment option for their patients.

Carboplatin had been administered neoadjuvantly. However, PET/CT showed a 1.8 cm hypermetobolic nodule in the right medial lung base. Surgical solutions and conventional radiation therapy were not options for this recurrence, so physicians agreed that SBRT was an excellent opportunity to eradicate or provide long-term suppression to the area of recurrence. Based on the 2-View LOT protocol, a prescription dose of 6,000 cGy was prescribed to the 82 percent isodose line and delivered over three fractions utilizing 111 non-coplanar beams. Eight months after treatment, a CT scan showed no residual tumor in the medial right lobe.

Lung Optimized Treatments: 1-View Another treatment protocol available with Erlangerâ&#x20AC;&#x2122;s CyberKnife System is the 1-View LOT function. The 1-View LOT protocol uses one of the CyberKnifeâ&#x20AC;&#x2122;s two orthogonally mounted cameras to enable fiducialfree, real-time adjustment of the beam to the respiratory motion of the tumor. This protocol was utilized for a 70-year-old woman with medically inoperable, stage I, poorly differentiated 2-view: A 3-D, axial, sagittal and coronal view of the large cell treated area highlighted in pink, as well as radiation carcinoma of dose shown in multicolored isodose lines. the right/mid upper lobe at the hilum. She was uses both of the systemâ&#x20AC;&#x2122;s mounted not a surgical candidate due to poor cameras to track tumor motion pulmonary function, and physicians during treatment. This function was did not believe that she would used to treat a 70-year-old female tolerate conventional radiation whose cancer had returned after therapy. However, foregoing therapy previous therapy. She received had an associated risk of progression treatment three-and-a-half years and lymphatic spread, which could prior with conventional radiation occur within a matter of months. therapy to 6,480 cGy over the Physicians chose to treat the course of 36 fractions. In addition, patient with non-invasive SBRT. four cycles of Taxotere and Lung Optimized Treatments: 2-View The CyberKnife LOT function offers several solutions for patients with lung tumors, including the 2-View option. The 2-View tracking solution

September 2016 | itnonline.com | Imaging Technology News

While side effects, including coughing and chest wall or rib tenderness are possible, the probability for this patient was low due to the location 0-view: A 3-D, axial, sagittal and coronal view of the of the tumor. treated area highlighted in pink, as well as radiation Based on the dose shown in multicolored isodose lines. 1-View LOT function, the treatment plan was placement of any fiducials and was developed using the MultiPlan unlikely to cause adverse side effects Treatment Planning System, and given the location of his lesion. a dose of 5,400 cGy was prescribed Based on the 0-View LOT protocol, to the 82 percent isodose line and the clinical team utilized both inhale delivered over four fractions, utilizing and exhale CT datasets to design 98 non-coplanar beams. Each fraction a treatment plan on the MultiPlan lasted approximately 36 minutes. Treatment Planning system. The Aside from reports of fatigue one tumor excursion was measured and week after completion of treatments, PTV margins drawn to account for the patient had no complaints. Seven the extent of tumor motion. months post-treatment, the patient The patient was treated using the reported doing well. She was not CyberKnifeâ&#x20AC;&#x2122;s automated IRIS Variable on oxygen and indicated she had Aperture Collimator. A prescription no shortness of breath. The treated dose of 6,000 cGy was prescribed lesion was no longer visible in CT to the 81 percent isodose line and scans taken at three- and six-month delivered over three fractions, lasting follow-ups. approximately 24 minutes each, utilizing 77 non-coplanar beams. Aside from reports of fatigue about Lung Optimized Treatments: 0-View a week after his final treatment, the The third LOT function that Erlanger patient had no complaints. One year uses with its CyberKnife System after treatment, at his follow-up visit, is the 0-View option. The 0-View the patient was still doing well with LOT protocol is used when a tumor no distress. cannot be clearly identified by either of the CyberKnifeâ&#x20AC;&#x2122;s two X-ray cameras. Erlanger used this feature Benefits of CyberKnife for with a 72-year-old male patient Early Stage Lung Cancer with a stage I lung cancer in the left The CyberKnife System provides upper lobe. His doctor had discussed early-stage lung cancer patients surgical options, including lobectomy at Erlanger with an alternative and mediastinal nodal sampling, treatment option to surgery. â&#x20AC;&#x153;Often as well as wedge resection. But the we get patients who wonder if there patient was considered a marginal is a treatment for them,â&#x20AC;? said David operative risk and he wanted to Taliaferro, CyberKnife coordinator explore less invasive interventions. at Erlangerâ&#x20AC;&#x2122;s CyberKnife Center. â&#x20AC;&#x153;We Physicians suggested SBRT find it very gratifying that now we as a non-invasive alternative to can tell our patients that we indeed surgery. SBRT using the CyberKnife have a treatment option for them. System is equivalent to surgical Not only that, but it is quick, painless wedge resection with respect to and non-invasive.â&#x20AC;? local control. Additionally, the LOT treatment would not require Case study supplied by Accuray. For More Information www.accuray.com

COMPARISON CHART Proton Therapy Systems

Proton Therapy Becomes Billion-dollar Industry By Jeﬀ Zagoudis

he global proton therapy market hit a major milestone in 2015, eclipsing the billion-dollar mark for sales orders and more than doubling the previous year’s total, according to market intelligence ﬁrm Medraysintell. This boom was evidenced by new proton therapy centers springing up all over the world, including 11 just since November 2015 — eight in the United States and three abroad in Hong Kong, Belgium and the Netherlands. (See the map to view the newest U.S. centers.) The new centers represent numerous vendors, and systems both large and small, underscoring the continuing evolution and spread of the technology.

1. Los Angeles Proton Center (announced Nov. 2015) 2. Texas Center for Proton Therapy, Irving (opened Nov. 2015) 3. St. Jude Children’s Research Hospital, Memphis, Tenn. (opened Dec. 2015) 4. Maryland Proton Therapy Center, Baltimore (opened Feb. 2016) 5. Arizona Mayo Clinic, Phoenix/Scottsdale (opened March 2016) 6. UF Health Cancer Center-Orlando (opened April 2016) 7. Delray Medical Center, Delray Beach, Fla. (announced April 2016) 8. University Hospitals, Cleveland (opened June 2016) Center announced

8 4

Center opened

1 5 3 2

Compact Systems

center would be Proton therapy’s explosive sales growth has occurred fully accepted with while the price of the technology has been dropping. all necessary certifications by June. This is largely thanks to the introduction and Pencil Beam Scanning proliferation of compact proton therapy systems. Proton therapy’s primary advantage over This has allowed the price of constructing a new traditional radiation therapy methods is its ability center to drop from nearly a quarter of a billion dollars to more precisely target cancerous tissue and spare to around $25 million. surrounding tissue and organs from radiation dose. Mevion Medical Systems brought the first In recent years, these treatments have become even compact proton therapy system to market when more precise thanks to the emergence of pencil it received U.S. Food and Drug Administration beam scanning (PBS), also known as spot scanning. (FDA) and CE mark approval for the S250 system This technique employs scanning magnets to direct in 2012. At the center of the compact system is thousands of ultra-fine proton streams (“pencil a superconducting synchrocyclotron, which is beams”) at the target volume in a U-shaped pattern significantly smaller than the traditional linear that deflects around healthy tissue. This advanced accelerator radiation source. The modular system technique has, in turn, allowed the development of is designed as a single-room solution, but can be IMPT. Using these techniques allows oncology teams adapted into a multi-room configuration. to refine treatment at some of the most difficult Varian entered into the compact proton therapy tumor sites, including the prostate, brain, base of market in 2014 by releasing a smaller version of its the skull and eyes. The majority of proton therapy original ProBeam system. The ProBeam Compact offers vendors now incorporate some form of pencil beam many of the same benefits of its predecessor, including scanning into their systems. dynamic peak scanning (allowing the application of radiation from different angles simultaneously for Treatment Planning intensity-modulated proton therapy), but its 250 MeV Another way that proton therapy differs from cyclotron is more space-efficient than traditional traditional radiation therapy is in the treatment radiation therapy linear accelerators (linacs). planning process. For the former, IBA (Ion Beam Applications S.A.) anatomical definition is the primary introduced the Proteus One factor when targeting the radiation compact proton therapy system beam, which passes straight in 2014. Proteus One is also a IBA through the target organ and comes single-room system offering www.iba-worldwide.com out the other side. Proton streams, several different delivery methods, on the other hand, can be calculated including intensity-modulated Mevion Medical Systems to stop inside the designated tissue proton therapy (IMPT) and imagewww.mevion.com to deposit the full radiation dose guided proton therapy. In April exactly where it is needed. 2016, IBA received CE mark for the ProTom International Computed tomography (CT) next generation of the Proteus One www.protominternational.com scans are utilized for proton accelerator, which the company treatment planning, but the key said would further help the system Varian information they provide are the gain acceptance in Europe. The www.varian.com Hounsfield unit (HU) measurements continent’s first Proteus One system Scranton Gillette Communications of the anatomical structures in the is located at the Centre Antoineobtained the product specifications target tissue. HU measurements Lacassagne in Nice, France, and IBA from the manufacturers. directly correlate to tissue electron said that with the new CE mark, the

Participants

6 7

densities, and can be converted into proton relative stopping power ratio (SPR) calculations by the treatment planning software. Philips released a proton therapy-specific version of its Pinnacle 3 treatment planning software in August 2013 following FDA approval. The module offers automated contouring and re-planning to quickly adapt treatment on the fly, fast commissioning and even combined protonphoton planning if physicians want to combine proton therapy and conventional radiotherapy. In November 2014, Philips announced a partnership with Mevion that would extend Pinnacle support to the new Hyperscan pencil beam scanning capability of the S250. RaySearch has included proton therapy and pencil beam scanning capabilities in its RayStation treatment planning software since version 4.0 was released in 2014. RayStation 5.0, released in February, features several enhancements that aid in proton therapy planning, including integration of 4-D CT datasets to accommodate treatment plans in areas with significant organ motion. Varian Medical Systems offers a proton-specific version of its Eclipse planning software, which is integrated with ProBeam and ProBeam Compact. The software employs numerous automation and standardization protocols to streamline workflow, including Smart Segmentation. Other features include Field Specific Target to help compensate for setup error, target motion and range uncertainty around the clinical target volume. itn

Comparison chart compiled by Imaging Technology News Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart.

Imaging Technology News | itnonline.com | September 2016

COMPARISON CHART Proton Therapy Systems Company name

IBA

Mevion Medical Systems Inc.

Product name

Proteus Plus

Proteus One

Mevion S250 Proton Therapy System

Mevion S250mx Proton Therapy System

FDA / CE mark clearance, year Year ﬁrst sold Number of sites installed Single room or multi-room conﬁguration System summary

FDA 2001/CE 2004 1995 29 Multi-room Proteus Plus is a made-to-measure, image-guided, intensity-modulated, proton beam technology whose protocols offer new hope to patients suffering from the broadest array of complex cancer conditions; safe, reliable and upgradable, the Proteus Plus system enables the proton therapy center to treat more patients, share clinical research and best practices; Proteus Plus is equipped with cutting edge technology including PBS (pencil beam scanning), CBCT (cone-beam CT), gantry rolling floor, robotic couch, virtual remote and ambient patient experience Proteus Plus offers excellence in treatment with the highly accurate pencil beam scanning (PBS) and fast treatment times; it also offers excellent upgradability to keep the institution partner at the proton therapy cutting-edge; IBA enables the partner institutions to share clinical research and best practices, and consult with IBA’s network of experts and extensive proton therapy user community

FDA 2014/CE 2016 2012 13 Single room IBA’s single-room solution, Proteus One, is a compact system that is easy to install, integrate, operate and ﬁnance; it is also scalable to be able to grow the radiation treatment unit over time; Proteus One is equipped with with cutting edge technology including PBS (pencil beam scanning), CBCT (cone-beam CT), gantry rolling ﬂoor, robotic couch, virtual remote and ambient patient experience

FDA 2012/CE 2012 2013 6 clinical + 3 under installation/contruction Single room with operation like a linac The Mevion S250 delivers high-quality, targeted radiation therapy for cancer patients at a fraction of the size and operating costs and with much higher operational eﬃciency than the legacy proton systems; its modular design and smaller footprint means that a Mevion S250 can be added to existing cancer facilities in even the most densely populated cities with extreme space constraints; it is an environmentally friendly system using less than 10 percent of the energy of legacy systems; overall the Mevion S250 oﬀers customers the best economics for building and running a proton facility in the current challenging reimbursement environment; the versatility of Mevion S250 greatly increases proton therapy accessibility for patients across the globe

FDA 2012/CE 2012 2013 1 under installation/construction Mutli-room with operation like a linac The Mevion S250mx delivers fully scalable proton therapy centers with two, three or four room options; each room is fully independent-providing inherent redundancy and guaranteeing 100% facility uptime, with beam availability 365 days a year; the Mevion S250mx safeguards and protects your financial outlays with lower initial cash flow demands, flexible installation and faster clinical ramp-up; it is an environmentally friendly system using less than 10% of the energy of legacy systems; overall the Mevion S250mx offers customers the best economics for building and running a proton facility in the current challenging reimbursement environment; the versatility of Mevion S250mx greatly increases proton therapy accessibility for patients across the globe

Proteus One oﬀers pencil beam scanning, which minimizes radiation exposure to healthy tissue; IBA’s compact solution emphasizes personalized comfort and accessibility while delivering the most clinically advanced form of proton radiation therapy; IBA enables the partner institutions to share clinical research and best practices, and consult with IBA’s network of experts and extensive proton therapy user community

Faster pencil beam scanning: scan a 1 liter volume in 6 secs; sharper lateral penumbra: automated spot collimation at all energies for a sharper penumbra; more robust IMPT: lower uncertainties at all steps of the treatment delivery - stable dosimetry, faster scanning, sharper spot and true adaptation; clinically optimized – operate just like a linac with advanced isocentric IGRT positioning; higher beam transport eﬃciency: lowest beam current required; lowest residual radioactivity; lowest shielding requirement; lowest neutrons created; and no waiting time to access accelerator; smallest footprint: less than 50% space required compared to the next larger system; fewer staﬀ : 2 therapist operation same as a linear accelerator; higher availability: 24/7 beam availability with quarterly 2 days maintenance; higher throughput: proven daily throughput of 45 patients/12 hr day; lower energy costs: same as operating 2 linear accelerators; faster ramp-up: proven 3 months to reach full patient ramp-up; faster deployment: installation in less than 9 months; lowest equipment cost and least complex system: 0 transport line

Isochronous cyclotron

Superconducting synchrocyclotron

Gantry mounted superconducting synchrocyclotron accelerator

230 > 2 Gy/min at isocenter Yes N/A (single room) N/A N/A N/A N/A N/A N/A Yes

250 MeV Up to 4 Gy/min Redundant - dose, flatness, symmetry, position 0 sec - dedicated accelerator N/A N/A High efficiency, low residual radioactivity and fastest service access Complete system: <100 kW beam on + < 50 kW beam off 15 tons 6 ft Low shielding requirements supported by high efficiency transport line with low beam current

230-250 Up to 4 Gy/min Redundant - dose, flatness, symmetry, position 0 sec - dedicated accelerator N/A N/A High efficiency, low residual radioactivity and fastest service access Complete system: <100 kW beam on + < 50 kW beam off 15 tons per accelerator 6 ft per accelerator Low shielding requirements supported by high efficiency transport line with low beam current

Pencil beam scanning (PBS)

Volumetric scattering beam delivery

Volumetric beam delivery with Hyperscan pencil beam scanning or scattering

240, 200

N/A

200/200

3-7

What diﬀerentiates your software from other vendors

ACCELERATOR Components of system

Beam energy range (MeV) 230 Intensity > 2 Gy/min at isocenter Monitoring Yes 10 seconds Beam switching time N/A Time of acceleration (sec) N/A Range of extraction time (sec) Eﬃciency of beam extraction N/A Power consumption (kW) N/A Total weight (tons) N/A External ring diameter (feet) N/A Shielding required Yes BEAM DELIVERY / SCANNING SPECIFICATIONS Type of delivery (scattering, scanning, Pencil beam scanning (PBS), scattering pencil beam, etc.) Bi-directional scanning; vertical (mm), 300, 400 horizontal (mm) Variance of focused beam dimension 3 - 6.5 (mm) Speed of scanning along beam axis N/A (MeV/sec) Dedicated scanning/universal Nozzle types oﬀered Field size 30 x 40 cm Beam uniformity 2.5%

N/A

2-3 mm sigma collimated; < 5 mm sigma uncollimated

N/A

< 50 msec layer switching; N/A

Dedicated scanning 24 x 20 cm 2.5%

Scattering 20 x 20 cm < 2.5%

Scattering and Hyperscan Scanning Nozzle 20 x 20 cm < 2.5%

Beam size and penumbra

Depending on energy

< 3 mm in air pneumbra

< 5 mm in air pneumbra; N/S

Beam position and stability

N/A

Better than 1 mm from target position in a plane perpendicular to beam at isocenter

Modulator wheel/ridge ﬁlter Collimation

Yes Yes

Modulator wheels Yes

Modulator wheels or N/A Yes

Compensators Dose monitoring

Yes Yes

Yes Internal - dual dose monitioring system

Yes or no Internal - dual dose monitioring system

Interlocks Beam gating

Yes Yes

Constant interlock monitoring N/A

Constant interlock monitoring Capable

Accelerator control system Record and verify Treatment planning system Simulation imaging equipment TREATMENT ROOM Localization system, on-board imaging systems Patient couch Gantry DESIGN Dimensions and ﬁeld size (mm) Cost Interference Secondary neutrons Electronics survival Other features OTHER FEATURES Estimated acceptance testing time Estimated commissioning time System maintenance considerations Approximate cost Financing options Other distinguishing features

Yes Yes, open vendor Yes, open vendor Yes, open vendor

Integrated and automated - with direct operation by the therapists Elekta Mosiaq, Varian Aria RaySearch RayStation, Philips Pinnacle, Varian Eclipse, Elekta XiO Open vendor

Integrated and automated - with direct operation by the therapists Elekta Mosaiq, Varian Aria RaySearch RayStation, Philips Pinnacle, Varian Eclipse, Elekta XiO Open vendor

Yes, stereoscopic and clinical CBCT at isocenter position since 2014 Robotic couch Yes

Yes, stereoscopic and clinical CBCT at isocenter position kV and diagnostic CT imaging - using verity patient positioning system since 2014 Robotic couch Robotic 6 degree of freedom Yes 190 degrees motion combined with 270 degrees robotic couch

Robotic 6 degree of freedom 190 degrees motion combined with 270 degrees robotic couch

N/A N/A N/A N/A N/A N/A

Internal: 37 x 32 ft. with shielding ~44 x 44 ft $3,000,000 to $5,000,000 None Low - optimized geometry Standard radiation therapy room Standard radiation therapy room

Typically 1 week but depends on selected options Typically 1 month but depends on selected options N/A N/A Yes Gantry rolling ﬂoor, PBS, Philips Ambient Experience, CBCT, virtual remote, dedicated PT software suite, open vendor allowing selection of the best features for your usage, range monitoring features, optimized workﬂow

1-2 weeks 4-6 weeks quarterly Availabe upon request Available The Mevion S250 is elegantly designed to deliver high-quality efficient proton therapy treatments-optimizing both the outcomes and the economics of proton therapy; built upon the world’s only gantry-mounted proton accelerator and benefitting from our patented direct beam technology, the Mevion S250 delivers on the therapeutic promise of proton therapy while enhancing beam quality, stability and uptime; the result is reduced system complexity, higher reliability and throughput, and lower capital and operating costs-making the Mevion S250 a compelling, financially viable solution for all cancer centers

1-2 weeks 4-6 weeks Quarterly Availabe upon request Available The Mevion S250mx is elegantly designed to deliver high-quality efficient proton therapy treatments-optimizing both the outcomes and the economics of proton therapy; built upon the world’s only gantry-mounted proton accelerator and benefitting from our patented direct beam technology, the Mevion S250mx delivers on the therapeutic promise of proton therapy while enhancing beam quality, stability and uptime; the result is reduced system complexity, higher reliability and throughput, and lower capital and operating costs-making the Mevion S250mx a compelling, financially viable solution for all cancer centers

September 2016 | itnonline.com | Imaging Technology News

kV and diagnostic CT imaging - using verity patient positioning system

Comparison Chart Compiled by Imaging Technology News Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart. Editor’s Note: Additional submitted information also appears on our website at www.ITNonline.com.

N/A = Not applicable N/S = Not speciﬁed

ProTom International

Varian Medical Systems Particle Therapy

Mevion S250i Proton Therapy System

Radiance 330 Proton Therapy System

ProBeam

ProBeam Compact

TBD TBD N/A Single room Hyperscan PBS with operation like a linac The Mevion S250i with Hyperscan technology overcomes existing pencil beam scanning uncertainties through its unique design; these unprecedented efficiencies are gained from an optimized delivery system with much faster energy layer switching; the result is a robust volumetric IMPT treatment delivered at hyper speed and with better lateral penumbra and invariant beam characteristics; by achieving energy switching in as little as 50 milliseconds, a one-liter target volume can be scanned in less than six seconds; this breakthrough technology makes the Mevion S250i ideal to deliver complex and robust IMPT dose distributions to targets close to critical structures or susceptible to movement; it is an environmentally friendly system using less than 10 percent of the energy of legacy systems; overall the Mevion S250i offers customers the best economics for building and running a proton facility in the current challenging reimbursement environment; the versatility of Mevion S250i greatly increases proton therapy accessibility for patients across the globe Faster pencil beam scanning: scan a 1 liter volume in 6 secs; sharper lateral penumbra: automated spot collimation at all energies for a sharper penumbra; more robust IMPT: lower uncertainties at all steps of the treatment delivery - stable dosimetry, faster scanning, sharper spot, and true adaptation; clinically optimized – operate just like a linac with advanced isocentric IGRT positioning; higher beam transport efficiency: lowest beam current required; lowest residual radioactivity; lowest shielding requirement; lowest neutrons created; and no waiting time to access accelerator; smallest footprint: less than 50% space required compared to the next larger system; fewer staff : 2 therapist operation same as a linear accelerator; higher availability: 24/7 beam availability with quarterly 2 days maintenance; higher throughput: proven daily throughput of 45 patients/12 hr day; lower energy costs: same as operating 2 linear accelerators; faster ramp-up: proven 3 months to reach full patient ramp-up; faster deployment: installation in less than 9 months; lowest equipment cost and least complex system: 0 transport line

FDA 2014 2009 2 Multi-room or single-room Scanning proton beam with 3 mm diameter at 250 MeV in air at isocenter; 16-ft diameter synchrotron with advanced beam control produces energies of 70-250 MeV for therapy, and up to 330 MeV for proton imaging; economically viable project due to lower construction cost and lower operating cost; system requires up to 40% less radiation shielding and operates with up to 55% greater power eﬃciency

FDA 2010/CE 2015 2002 4 clinical, 11 under construction Multi-room configuration; single room expandable Varian’s ProBeam proton therapy system consists of one proton accelerator, and one or multiple treatment rooms, which can be configured to rotational gantries or horizontal fixed beam rooms; gain confidence that you’re on target with the 360° CBCT technology that has been developed and is utilized on over 4,500 Varian linacs; treatment flexibility with a full 360° rotational gantry and ad-hoc kV imaging that will allow you to image anytime during treatment at your current gantry angle; experience the convenience of treating larger tumors with the 30 x 40 cm field size plus increased treatment range for shallow tumors without the use of a range shifter

The treatment delivery control system enables fast energy switching, rapid beam scanning, variable duration extraction and integrated workﬂow guidance; safety and accuracy of system operation are assured at all times; having been developed by experienced clinical and technical operators of proton therapy systems, the system is intuitive, workﬂow-centric, user-friendly and patient-focused

Varian offers a completely integrated end to end solution, from the Eclipse treatment planning system to Aria oncology information system; Dynamic Peak Scanning optimizes the dose applied to each point within the treatment area by combining the irradiation from multiple angles and real-time dose measurement; Dynamic Peak Imaging enables onboard kV imaging with optional, fully integrated cone-beam CT and ad hoc imaging; Dynamic Peak Workflow offers an intuitive interface that simplifies complex tasks by automating multiple treatment fields and enabling quick treatment with single-button procedure

FDA 2010/CE 2015 2016 N/A Single room configuration Varian’s ProBeam Compact proton therapy system incorporates the complete functionality and features of the ProBeam system in a single room configuration without compromise; Varian’s ProBeam system consists of one proton accelerator, and one rotational gantry treatment room; gain confidence that you’re on target with the 360° CBCT technology that has been developed and is utilized on over 4,500 Varian linacs; treatment flexibility with a full 360° rotational gantry and ad-hoc kV imaging that will allow you to image anytime during treatment at your current gantry angle; experience the convenience of treating larger tumors with the 30 x 40 cm field size plus increased treatment range for shallow tumors without the use of a range shifter Varian offers a completely integrated end to end solution, from the Eclipse treatment planning system to Aria oncology information system; Dynamic Peak Scanning optimizes the dose applied to each point within the treatment area by combining the irradiation from multiple angles and real-time dose measurement; Dynamic Peak Imaging enables onboard kV imaging with optional, fully integrated cone-beam CT and ad hoc imaging; Dynamic Peak Workflow offers an intuitive interface that simplifies complex tasks by automating multiple treatment fields and enabling quick treatment with single-button procedure

Gantry mounted superconducting synchrocyclotron accelerator

RFQ linear injector; synchrotron

230 MeV Up to 2 Gy/min / liter Redundant - spot positio and intensity 0 sec - dedicated accelerator N/A N/A High efficiency, low residual radioactivity and fastest service access Complete system: <100 kW beam on + < 50 kw beam off 15 tons 6 ft Low shielding requirements supported by high efficiency transport line with low beam current

70-250 MeV for therapy; up to 330 MeV for proton imaging 2 Gy/liter/minute dose rate; proton beam current ranges from < 0.1 nA to 0.5 nA at isocenter Redundant ionization chambers monitored by ﬁrmware and software <1.2 s average N/S 0.1 to ≥ 5 N/S 3,879 kWh/month, 10 hrs/day, 3-room proton therapy center 16 tons 16 Approximately 5-ft HD concrete around accelerator vault; lowest in industry

Superconducting cyclotron, beam transport system (incl. energy selection system module), accelerator control system 70 to 225 MeV N/S Yes < 30 sec room switching time; < 0.9 sec layer switching time N/A (microseconds) CW (no pulsed beam; continuous wave/ beam) > 80% 185 kW (cyclotron during irradiation) 90 tons (cyclotron) 3.2 meter Yes

Superconducting cyclotron, beam transport system (incl. energy selection system module), accelerator control system 70 to 225 MeV N/S Yes N/A N/A (microseconds) CW (no pulsed beam; continuous wave/ beam) > 80% 185 kW (cyclotron during irradiation) 90 tons (cyclotron) 3.2 meter Yes

Volumetric beam delivery with Hyperscan pencil beam scanning

3-6 mm diameter scanning beam

Pencil beam scanning

200, 200

Up to 30 x 40 cm ﬁeld size

250 x 250 mm (optional 300 x 400 mm)

2-3 mm sigma collimated; < 5 mm sigma uncollimated

< 1 mm for 250 MeV; < 1.4 mm for 69 MeV

< 1 mm

< 50 msec layer switching

N/S

10 MeV in < 0.9 sec

Hyperscan Scanning Nozzle 20 x 20 cm < 2.5%

Pencil beam scanning 250 x 250 mm (optional 300 x 400 mm) N/S

2-D Gaussian beam proﬁle, nominal sigma 4 mm in air at isocenter, lateral 80%/20% penumbra 1.13 sigma

Better than 1 mm from target position in a plane perpendicular to beam at isocenter

Scanning only Up to 30 x 40 cm field size For pencil beam scanning, target volume dose uniformity is often used as a measure of the ability of the beam delivery system to deliver a treatment plan having uniform target dose within the allowed variance in dose over the defined target volume as measured in a water phantom; this test is a measure of the machine’s ability to deliver the spot size, spot spacing and energy per spot/layer as prescribed by the plan; dose reproducibility: γ (2 mm, 2%) for measurements compared to the calculated dose distribution at > 95% pass rate The Radiance 330 lateral penumbra should not exceed the spreading in water caused by multiple scattering by more than 2 mm, except for low energies; therefore, in such cases it may be necessary to provide collimation for proton beam scanning delivery; beam emittance of the Radiance 330 beam extracted from the synchrotron is between 1 x 10-6 and 2.5 x 10-6 m-rad, probably among the smallest emittances of any of ProTom’s competitors, and the steering in the gantry has a resolution of well below 0.1 mrad The displacement of irradiated spots from the predefined position will in all instances be < 1.5 mm

N/A Yes

N/A A motorized translation slide is available for collimators, range shifters and compensators

No Internal - dual dose monitioring system

A motorized translation slide is available for collimators, range shifters and compensators Multi-strip ionization chambers are used to determine beam position and profile; a multi-layer ionization chamber can be inserted to determine the beam range, redundantly from the information obtained from the synchrotron; instrumentation beam stops can be used to monitor beam current Integrated, multiply-redundant firmware, hardware and software-based safety and control system Supported via external interface to gating system of customer choice; extraction duration of the synchrotron is variable “on-the-fly” (0.1 to ≥ 5 s); extraction cycle may be arbitrarily started or stopped N/S Owner’s choice Owner’s choice Owner’s choice

Better than ±1 mm from target position in a plane perpendicular to beam at isocenter Not necessary with IMPT scanning Not necessary for most of the treatment cases; to even improve the lateral penumbra, an optional aperture mounting is supported for pencil beam scanning nozzle N/A Yes

Yes Yes

Yes Aria for record and PTC for veriﬁcation or third party system Eclipse or third party treatment planning system Yes, open vendor

kV and integrated CBCT

Robotic 6 degree of freedom 190 degrees motion combined with 270 degrees robotic couch

Radiance 330 includes orthogonal pair X-ray imaging system, and supports the owner’s choice of volumetric imaging system through industry standard interfaces Owner’s choice 180 degree with 10 degree overtravel at top and bottom

6 degree of freedom robotic couch 380° rotational (±190° enabling extended travel)

Internal: 37 x 32 ft. with shielding ~44 x 44 ft $3,000,000 to $5,000,000 None Low - optimized geometry Standard radiation therapy room Standard radiation therapy room

Up to 30 x 40 cm field size Variable, depending on number of treatment rooms; call for quote Tested and verified safe as part of FDA clearance Tested and verified safe as part of FDA clearance Tested and verified safe as part of FDA clearance A single gantry system can be installed within the space of ~2 linac vaults

250 x 250 mm (300 x 400 mm optional) Available upon request N/A N/A N/A Available upon request

1-2 weeks 4-6 weeks Quarterly Available upon request Available The Mevion S250i with Hyperscan is elegantly designed to deliver high-quality efficient proton therapy treatments-optimizing both the outcomes and the economics of proton therapy; built upon the world’s only gantry-mounted proton accelerator and benefitting from our patented direct beam technology, the Mevion S250i delivers on the therapeutic promise of proton therapy while enhancing beam quality, stability and uptime; the result is reduced system complexity, higher reliability and throughput, and lower capital and operating costs-making the Mevion S250i a compelling, financially viable solution for all cancer centers

Installation and technical commissioning ~19 months Installation and technical commissioning ~19 months Service contract is required for uptime guarantee after warranty Variable, depending on number of treatment rooms; call for quote Possibly - depending on credit rating and other risks, call to discuss Future capability for proton tomography

1-2 weeks Dependent on customer and conﬁguration N/S N/A Yes Integrated on-board 360° CBCT imaging, Dynamic Peak workﬂow, integration and scanning, gating, repainting, single vendor delivery and software solution, Eclipse treatment planning and Aria oncology information system

1-2 weeks Dependent on customer N/S N/A Yes Integrated on-board 360° CBCT imaging, Dynamic Peak workﬂow, integration and scanning, gating, repainting, single vendor delivery and software solution, Eclipse treatment planning and Aria oncology information system

< 5 mm in air pneumbra

Constant interlock monitoring Capable Integrated and automated - with direct operation by the therapists Elekta Mosaiq, Varian Aria RaySearch RayStation and Philips Pinnacle Open vendor kV and diagnostic CT imaging - using verity patient positioning system

Imaging Technology News | itnonline.com | September 2016

Radiation Oncology | PRODUCTS | Treatment Delivery Platform for Radiation Therapy

Strength in NUMBERS Outcomes Driven. Results Based.

Accuray Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radixact Treatment Delivery Platform for radiation therapy. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray Precision Treatment Planning System and iDMS Data Management System. These next-generation hardware and software solutions, which together make up the new Radixact system, enable faster, more eﬃcient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing re-treatment. The system features a more powerful linear accelerator, megavoltage computed tomography (MVCT) imaging and helical treatment delivery, so clinicians can apply highly conformal and homogenous dose distributions to any target volume while precisely sparing normal healthy tissue during each treatment fraction. The new Accuray Precision Treatment Planning System with smart, automated workﬂows and midcourse decision-making tools enables clinicians to adapt delivery to changes in tumor size, shape and location within the patient.

DEPLOYMENT

3 in 3 SYSTEMS

FASTER

MONTHS

Accuray | www.accuray.com

PROTON THERAPY CENTERS

QUICKER RAMP-UP zero to full capacity in 3 months

HIGHER THROUGHPUT 24/7 beam availability and 98% uptime

GREENER

PROTONS

up to 90% LESS energy usage

FEWER STAFF up to 75% less–operational & clinical

Proton Therapy Center University Hospitals in Cleveland recently held a ceremony to mark the completion of its new $30 million proton therapy center, the ﬁrst in the state of Ohio. The 11,000-square-foot center was scheduled to begin accepting patients in July. The project has been in development since 2011, when University Hospitals agreed to purchase a proton therapy system from Mevion Medical Systems. The proton therapy center will reportedly be able to treat 20-25 patients a day. UH is also expected to enroll the center in several national clinical trials and simultaneously develop its own trials to expand the use of proton therapy. University Hospitals in Cleveland | www.cleveland.com

90% SMALLER FOOTPRINT

optimally designed with therapy in mind

Transformative Proton Therapy. Superior Performance. Proven Results. Go to www.protontherapy.com to ﬁnd out why Mevion is the right partner for your cancer center and your patients.

Visit us at ASTRO booth 10031.

September 2016 | itnonline.com | Imaging Technology News

Stereotactic Radiosurgery System Elekta’s Leksell Gamma Knife Icon radiosurgery system has been cleared for clinical use by both the Japanese Ministry of Health, Labour and Welfare and the Nuclear Regulatory Commission in the United States. Icon offers physicians increased flexibility for treatment of certain brain tumors, vascular malformations and functional disorders by allowing either frame-based or frameless methods to immobilize the patient’s head, while ensuring the highest level of precision. This allows patients with larger brain tumors and lesions close to critical brain structures to be treated with Gamma Knife accuracy and confidence. Leksell Gamma Knife Icon received 510(k) approval from the FDA in August 2015 and CE marking in June 2015. It has also been cleared by the MFDS for clinical use in The Republic of Korea. Elekta | www.elekta.com

Solutions Applied | A CASE STUDY | Sponsored by RaySearch

Robust Treatment Planning at Europe’s First ProteusOne Center

new proton therapy center at Centre AntoineLacassagne (CAL) in Nice, France, will soon begin treating patients with IBA’s ProteusOne system and the RayStation treatment planning system. The facility is one of only two proton therapy centers in France, and the first in Europe with the ProteusOne, IBA’s compact pencil beam scanning proton therapy system. Today, CAL treats around 2,300 patients per year using a wide range of treatment techniques and systems, including photon therapy, TomoTherapy, SBRT, brachytherapy and CyberKnife robotic radiosurgery. With the ProteusOne, the center will also be able to deliver highly precise treatment for pediatric cancers, as well as for complex cases such as cancers of the head and neck or spinal cord. CAL anticipates that its proton therapy center will treat around 250 patients per year when up to speed. Jérôme Doyen, M.D., a physician at CAL, said that expanding proton therapy capabilities was a natural step. “We felt we had gone as far as possible in improving the quality of photon therapy plans. Proton therapy will enable us to take precision to new levels. We are one of the pioneers in France, but the technology is becoming more accessible, and I am certain this treatment technique will expand to other centers during the next few years,” he said. The proton therapy technique will enable the center to treat more complex cases, including

Clinical example of robustness settings for a glioma case. A 3 mm patient position uncertainty and a 3 percent range uncertainty was chosen for this case. These values will be used in a minimax optimization. This means that for every iteration, the optimization engine will minimize the function value for the worst case scenario using the provided patient position uncertainty and range uncertainty values.

The proton therapy center at CAL, Nice.

radioresistant cancers such as chondrosarcomas and chordomas that need high radiation doses, for example up to 74 Gy. It will also make it possible to treat tumors close to organs at risk, for example in the base of the skull, or in areas where surgery is difficult, such as the spinal cord or intestines. The precision of proton therapy is also valuable when treating children. “Not because we achieve better tumor coverage,” Doyen said, “But to reduce the integral dose to avoid long-term consequences such as radiation-induced cancers. Proton therapy also has been shown to reduce hormonal disorders over

the treatment planning system for the new facility. RayStation’s robust optimization method takes geometric and dosimetric uncertainties into account, including interfractional movement and range and positioning uncertainties. It calculates for various possible

“We felt we had gone as far as possible in improving the quality of photon therapy plans. Proton therapy will enable us to take precision to new levels.”

— Jérôme Doyen, M.D.

the long term. Some 10–20 percent of cancer patients could benefit from proton therapy, such as young adults with Hodgkin’s lymphoma or patients with left-sided breast cancers, among other indications.” Robust optimization was a key reason for choosing RayStation as

scenarios, ensuring the plan is effective and accurate even when treatment conditions are not optimal. In proton therapy, this makes it possible to plan the dose for the CTV, instead of the PTV, which is generally used in conventional radiation therapy. Anais Gerard, a medical physicist at CAL, said, “RayStation is the only commercial treatment planning system that offers this robust optimization. Computation speed is a key component when running multiple scenarios of optimization; RayStation is impressively fast, even when running as many as 21 scenarios for one case.” Gerard commented that as a pioneering cancer center, it is essential for CAL to ensure the ability to meet future needs. “RayStation is part of our long-term approach. We

have a variety of treatment machines, and we needed a treatment planning system that would enable us to plan for all our treatment techniques in the future,” she said. “RaySearch releases new software versions every year that take user requests into account. It is great to work with such a responsive team.” Another useful feature is RayStation’s scripting capability, which gives the flexibility to personalize the treatment planning system according to the center’s needs and workflow. Marie Vidal, a medical physicist at CAL, added that setting up RayStation for the ProteusOne system was more straightforward than expected. “We thought we would have to adjust the beam model when commissioning RayStation for this new synchrocyclotron technology, but it was a one-shot modeling. We got very good results and high precision on Bragg peak and spot measurements, as well as for flatness, symmetry, penumbra and size of lateral fields.” Vidal added, “We are also looking forward to running our dose calculations in the Monte Carlo algorithm for particle therapy, which is coming in the next release later this year.” Case study supplied by RaySearch.

For More Information www.raysearchlabs.com Clinical example of proton treatment with robust optimization for a glioma case. Imaging Technology News | itnonline.com | September 2016

IMAGING

Nuclear Medicine

Advanced

Molecular Imaging Advanced imaging and hybrid modalities are evolving to aid and personalize future patient population care

By Kirill Shalyaev, Ph.D.

dvanced imaging and hybrid modalities, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT and single-photon emission computed tomography (SPECT)/CT are showing significant growth and will continue to do so, despite some slowdown in overall imaging volume due to the changing reimbursement landscape. There are ongoing studies and data that demonstrate the value of molecular imaging and nuclear medicine solutions in both traditional and new use cases. Today, the value in these innovations and the added confidence they provide in informing better patient care is more widely recognized. As a result, PET/CT volume in particular is expected to rise steadily over the next 10 years, driven by new indications, novel tracers obtaining regulatory approval and expanded insurance coverage. Nuclear medicine and molecular imaging have come a long way and continue to evolve, advancing their impact on diagnosis and treatment. There are a number of factors driving the evolution of the nuclear medicine and molecular imaging market, which include a rise in chronic disease, the significant growth of aging population and increasingly limited global resources.

Data Integration and Analytics No solution alone can address a growing, aging population and increase in chronic and lifestyle diseases, among other pain points in our global healthcare system. This requires an integrated approach that accesses and analyzes data drawn from a multitude of sources, making critical information available to patients and caregivers where, how and when they need it. Molecular imaging is evolving 20

September 2016 | itnonline.com | Imaging Technology News

to fulfill these needs, and providing better access to more integrated diagnostic imaging technology will continue to be critical in improving patient care. As the healthcare industry shifts toward valuebased care, clinician workflow has become more demanding, but it is not only about integrating data for primary care physicians. Healthcare institutions want and need imaging solutions that provide integrated patient information, automated processes and increased diagnostic confidence on repeat tests. Molecular imaging and nuclear medicine innovations that are primed for today and tomorrow should be able to address three key areas.

Improved workflow and automation. Clinicians need imaging solutions that provide integrated patient information and automated processes. The latest patient-centered imaging can improve workflow efficiencies via fast scans, and high image quality at a low dose that in turn can help better manage patient care.

Integrated patient data. As clinicians look to implement more pre-emptive and deﬁnitive treatment programs, they require access to integrated, comprehensive data on the patient’s

Enabling personalized medicine. Molecular imaging’s role in disease management is becoming increasingly important. It is critical for clinicians to be able to identify a disease in an early stage, and assess

diagnostic history and not just an image. Through the technologies available, physicians will begin to see these molecular imaging technologies as more than a scanner, but as a whole solution that helps to integrate quality, quantiﬁcation and analytics.

PHOTO COURTESY OF VITAL IMAGES

“PET/CT volume in particular is expected to rise steadily over the next 10 years, driven by new indications, novel tracers obtaining regulatory approval and expanded insurance coverage.”

There is a growing focus on early diagnosis and prevention. Here, PET/CT imaging is used to look inside the stress center of the brain.

their patient’s response to therapeutic intervention. Access to more data enables clinicians to customize treatment based on their patient’s anatomy, and specific molecular and cellular patterns of disease. Data coupled with digitally advanced imaging tools can help clinicians make faster and more confident disease detection, leading to more patient-specific therapy guided by molecular imaging.

Three Trends Driving Innovation In addition to the aforementioned drivers that are spurring industry growth, three key trends have emerged and are informing the next generation of solutions, innovations and breakthroughs. Trend No. 1: Increased patient engagement is driving demand for data. As the industry continues to move toward more patient-centric care and patients become increasingly more aware and involved in their health, there is a growing focus on early diagnosis and prevention. Nuclear medicine and molecular imaging are responding by refocusing on digital technologies as well as actionable data and analytics. Clinicians need access to clearer, sharper images and more cost-eﬀective technology that provides quantitative and qualitative measurements. Being able to extract quantiﬁed, meaningful data allows physicians to better assess the severity of a condition or disease and measure the degree of change over the course of treatment. Rich data can be turned

into actionable insights that help to shape, drive and inform patient care and treatment, earlier and throughout the cycle of care. Trend No. 2: Making personalized medicine a reality. As personalized medicine continues to influence how we deliver care, advances in nuclear medicine and molecular imaging technologies are making it more and more critical in the care continuum. For example, new radiotracers represent a major development that will take nuclear medicine beyond the standard FDG (fluorodeoxyglucose), which will enable greater specificity to target individual tumor types or disease processes. Advances in imaging equipment in digital technology, such as digital PET/CT, have demonstrated that they can provide approximately twice the volumetric resolution, sensitivity gain and quantitative accuracy when compared to analog systems, enhancing patient care. Lastly, in order for physicians to deliver personalized treatment, they need quantitative data that has driven the delivery of advances that give providers more access to actionable information and analytics. Trend No. 3: Integrated solutions for a 360-degree view of the patient. In healthcare, there is no one-size-fits all approach — each patient carries unique characteristics and insights that create a one-of-a-kind care journey. Clinicians (and patients) are looking for solutions that help deliver treatment

earlier along that care path, with the aim of providing more preventative, personalized solutions. To do that, clinicians are seeking more pre-emptive and definitive treatment programs, and are demanding access to integrated, comprehensive data on the patient’s diagnostic history. Since radiology and nuclear medicine continue to remain at the heart of diagnosis, access to more integrated diagnostic imaging technology will continue to be critical for improving patient care. With this, we are seeing the advent of more integrated, patient-focused solutions that deliver enhanced image quality through real-time tools tailored to help elevate clinical performance throughout the cycle of care. As our population continues to age and see a rise in multiple complex, chronic diseases such as cancer, dementia and cardiac disease, physicians will find they need more than just scanners to help provide accurate treatment and diagnosis. Nuclear medicine and molecular imaging will continue to advance and develop as an integral part of radiology and diagnostic imaging. Features and capabilities will continue to be innovated to fit the needs of the physicians in need of better quality imaging solutions to provide, which will be critical to improving patient care. itn Kirill Shalyaev Ph.D., is vice president and general manager of advanced molecular imaging, Philips Healthcare. Imaging Technology News | itnonline.com | September 2016

Imaging | PRODUCTS | High-DeƤnition Pulmonology Endoscopy System Pentax Medical launched a high-definition (HD) pulmonology endoscopy system in the European, Middle Eastern and African (EMEA) markets. The new Defina system in Pulmonology combines a state-of-the art HD processor with i-scan imaging technology and two highly maneuverable HD bronchoscopes. This combination serves to deliver high HD image quality, which subsequently supports clinical outcomes across the complete range of diagnostic and therapeutic applications. The HD Defina system delivers sharp and clear image quality, enabling rapid and highly detailed visualization for the improved evaluation of anatomical details of the bronchial mucosa. This in combination with i-scan technology facilitates the precise detection and demarcation of suspicious areas and assists in characterization of abnormalities to support therapeutic decisions. Fully complying with increasing hygiene requirements, the system uses disposable accessories to reduce the risk of cross-contamination. It is also STERRAD-compatible, ensuring that it is clear of multidrug-resistant and extreme drug-resistant mycobacterium. Pentax Medical | www.pentaxmedical.com

Advanced Image Processing on Ultrasound ContextVision has signed a contract to bring its US PLUSView ultrasound image enhancement software to hand-held iOS-based mobile devices. The move will make advanced image processing software available on small hand-held devices, making ultrasound examinations reachable and affordable to more users outside traditional clinics. US PLUSView offers a number of features for hand-carried use, including superior edge enhancement; excellent soft tissue differentiation; enhanced margin continuity; efficient line connectivity; clear lines and edge conspicuity; and great grayscale contrast. ContextVision | www.contextvision.com

CT Dose Module RamSoft has integrated with Scannerside to introduce a new CT dose module. Through real-time radiation dose tracking, analytics and reporting, the module enables healthcare facilities to comply with computed tomography (CT) regulations, practice medical imaging more responsibly and improve patient safety measures. The module is designed to maximize workflow automation while complying with Joint Commission requirements. It is equipped with the capability to seamlessly pull information from CT dose report screens and bookmark the values right into the radiology report, saving time for the radiology staff and eliminating data entry errors. The module is a 100 percent cloud-based system that allows users to evaluate usage protocols, compare rates against national averages, supply patients with easy-to-understand printouts, automate dose reports and streamline exam workflow. RamSoft | www.ramsoft.com

MRI-guided Focused Ultrasound Device The U.S. Food and Drug Administration (FDA) recently approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors. To determine if the ExAblate Neuro treatment is appropriate, patients should first have MR and CT scans. Those undergoing treatment with the MRI-guided device lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus for treatment. Treatment with transcranial focused ultrasound energy is administered with incremental increases in energy until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment. Data supporting the safety and effectiveness of the device system included a double-blind control trial involving 76 patients with essential tremor who had not responded to medication therapy. Patients treated with the ExAblate Neuro showed nearly a 50 percent improvement in their tremors and motor function (composite tremor/motor function score) three months after treatment compared to their baseline score. InSightec | www.insightec.com 22

September 2016 | itnonline.com | Imaging Technology News

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February 2015

COMPARISON CHART Radiation Dose Management

Dose Monitoring Making a Diơerence By Jeﬀ Zagoudis

or all the benefits of medical diagnostic imaging, radiation exposure to both the patient and the operator remains a major safety concern. Various studies have illustrated the harmful effects of excess radiation dose, but much is still uncertain as to its precise impact. New research suggests, however, that occupational radiation safety for radiologists has improved in recent years. The study, conducted by a team from the National Cancer Institute in Bethesda, Md., found that radiologists who graduated medical school after 1940 do not face increased mortality rates from radiation-related causes, including cancer and cerebrovascular disease. Researchers looked at records from the American Medical Association Physician Masterfile to compare cancer incidence and mortality rates of radiologists who graduated between 1916 and 2006 with psychiatrists (chosen as the control group because they were unlikely to have occupational radiation exposure). Male radiologists who graduated after 1940 were found to have lower incidences in both categories compared to psychiatrists.1 As studies like this seem to support safety efforts of the last few decades, a number of new solutions released in the past 12 months continue to expand dose monitoring capabilities and increase safety for staff and patients.

XR-29 and CT Dose One of the most recent standards published related to occupational radiation safety in radiology is the XR-29 standard, released by the National Electrical Manufacturers Association (NEMA) in 2013. XR-29 focuses on optimizing radiation dose speciﬁcally for computed tomography (CT) and positron emission tomography (PET)/CT through four scanner features: DICOM Radiation Dose Structured Reports, CT Dose Check, automatic exposure controls, and pediatric and adult reference protocols. The mandates became eﬀective Jan. 1 of this year. In May, Medic Vision released third-party software to help make existing 4-, 8- and 16-slice scanners XR-29 compliant. SafeCT-29 analyzes dose data in real

time and alerts the operator if the dose is too high. If so, the software automatically prevents the scan until the dose is either adjusted or confirmed and justified. All events and actions are recorded, logged and available for review and audit. RamSoft introduced a new CT Dose Module in July, a cloud-based system that integrates with Scannerside dose software. The module pulls dose information directly from CT dose report screens and bookmarks the values directly into the radiology report; this helps streamline exam workflow and eliminate data entry errors. The module also helps evaluate usage protocols, compare dose rates against national averages and generate easy-to-read printouts for patients.

“The study, conducted by a team from the National Cancer Institute in Bethesda, Md., found that radiologists who graduated medical school after 1940 do not face increased mortality rates from radiation-related causes, including cancer and cerebrovascular disease. ” GE Healthcare released the DoseWatch Explore software — which tracks, analyzes and reports on practice-level CT dose data for GE’s CT systems — at the 2015 Radiological Society of North America (RSNA) annual meeting. The Web-based, clouddeployed solution provides an automated tool for dose data and analytics with no user-side IT integration required. DoseWatch Explore is part of GE’s Dose Excellence consulting program, where the company’s experts will help users create a dose team and customize a multi-step plan to reduce dose variation, manage risk, streamline reporting and enable quality imaging at the lowest dose possible.

Multimodality Dose Solutions Cerner displayed an updated version of its Radnet RIS (radiology information system) at RSNA 2015. The system brings dose data into the Cerner Millennium electronic health record (EHR), including it in the

Participants Agfa Healthcare www.agfahealthcare.com

Medic Vision Imaging Solutions

Bayer Healthcare Novarad

GE Healthcare PACSHealth LLC www.dosemonitor.com

1. Berrington de Gonzalez, A., Ntowe, E., Kitahara, C.M., et al. “Long-term Mortality in 43,763 U.S. Radiologists Compared with 64,990 U.S. Psychiatrists,” Radiology. Published online July 19, 2016. http://dx.doi. org/10.1148/radiol.2016152472. Accessed Aug. 6, 2016.

Philips Healthcare

Siemens Healthineers

www.usa.philips.com

www.usa.siemens.com

ScImage

Volpara Solutions

www.scimage.com

www.volparasolutions.com

Comparison chart compiled by Imaging Technology News

Sectra

Scranton Gillette Communications obtained the product speciﬁcations from the manufacturers.

Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart.

www.novarad.net www.gehealthcare.com

the globe with clinical data to streamline and enhance the decision-making process. The new Protocols include a dose function, which allows users to compare their current dose values against institutional and national reference values, or benchmark their performance against other facilities for similar exams. Images are called up using picture archiving and communication system (PACS) Web viewers, and all information is provided in a patient-centric view. Dose values are normalized by patient size. SST Group’s RDM (Radiation Dosage Monitor) solution, also on display at RSNA 2015, employs a dose archive and communication system (DACS) to store and manage both current and historical patient dose data, including all captured diagnostic, interventional and image-guided surgical ionizing events. RDM is compatible across all imaging modalities from all manufacturers, with a browserbased user interface that collects data directly from the scanner for real-time monitoring and alerts. itn Reference

www.medicvision.com www.bayerhealthcare.com

technologist and radiologist workflow as well as the exam report. Users can also include historical dose information in the patient chart. RSNA 2015 also saw the introduction of version 2.0 of Philips’ DoseWise Portal, now featuring an enhanced dashboard for patient dose data viewing. The second version also includes a peak skin dose reporting feature for fluoroscopy procedures and further integration with DoseAware Xtend for improved staff exposure data, bringing staff and patient dose data together into the user interface. Siemens rolled out several new modules, or Protocols, for its teamplay cloud-based collaboration network at RSNA. Teamplay connects radiologists, physicians and patients around

www.sectra.com

Imaging Technology News | itnonline.com | September 2016

COMPARISON CHART Radiation Dose Management Company name Product name FDA cleared, year

Agfa HealthCare DoseMonitor 2012

Bayer Healthcare LLC Radimetrics Enterprise Platform Registered as a Class 1 medical device under FDA 2013 2013 The Radimetrics Enterprise Platform by Bayer is a solution for integrated radiation and contrast dose management; integrating seamlessly with radiology workﬂow and hospital IT infrastructure

DoseWatch Compliant w/ FDA regulations

GE Healthcare DoseWatch Explore Compliant w/ FDA regulation

Medic Vision Imaging Solutions Ltd. SafeCT Enterprise 2011

CE mark approval, year Brieﬂy explain what the software monitors, reports

2013 Automated ionizing dose data collection, reporting and analysis solution

At what level is dose monitored and analyzed (e.g., patient, study, department, site)

Patient, study, modality and facility

Patient cumulative, study, acquisition, injection and organ dose levels; by modality, enterprise, site, equipment, staﬀ, protocol, specialty

Patient, series, study and cumulative dose metrics Series-level dose and protocol details for conw/support for multi-site/department conﬁgurations nected GE CTs, excludes directly identiﬁable patient information

All, including: patient, study, protocol, scanner All, including: patient, study, protocol, scanner model, scanner vendor, department, site, model, scanner vendor, department, site, organization, operator organization, operator

What modalities can be monitored

CT, XA, DR and MG, NM, PET

CT, interventional/cardiovascular, mammography, radiography, surgical/mobile C-arms, ﬂuoroscopy Yes, ACR, national and custom DRLs are supported; segment by age, weight, height, study and series type

Yes

Manual upper threshold entry only

All

Does software oﬀer pediatric DRLs

Yes

CT, CT/PET, PET, CR/DR, MG, angiography/interventional/cardiovascular/fluoroscopy, nuc med, MRI Yes, customizable patient cumulative, exam and acquisition DRLs, based on a percentile of local performance, or standards from registries and regulatory bodies Offers DRLs filtered to patient age, gender, weight, height, BMI, diameter and/or WED

GE Healthcare CT systems

Does the system support diagnostic reference levels (DRLs) set locally, by registries or by regulatory bodies

No, patient speciﬁc information is not captured

Yes

How does the software help providers comply with Joint Commission requirements

Yes

Tracks and records exam, dosimetric information, overexposures and protocol parameters for each exam for each CT connected

N/A

Does software help meet dose recording requirements set by the state of California, Texas or other U.S. states

Yes

N/A

If you are an OEM, what vendors oﬀer your solution

N/A

What diﬀerentiates your software from competitors

Feature set, ease of use, straightforward implementation

SafeCT-29 is the only FDA-cleared third party XR-29 solution

SafeCT is the ﬁrst and only system to deliver both dose monitoring/reporting and low-dose CT image enhancement in one solution

MODALITIES TRACKED / METHODS SUPPORTED Computed tomography Dosimetric information Protocol parameters

All including CTDIvol, DLP, SSDE, eﬀective dose, organ speciﬁc dose All

Size speciﬁc dose estimate

Yes

Quality review

Yes

Data collection method

RDSR, DICOM header, OCR, proprietary dose estimation

How is dose data transferred into software

DICOM

2012 DoseWatch is an enterprise-wide dose management solution that captures, tracks, alerts and reports on patient radiation dose; analytics assist in quality control and dose optimization

SafeCT-29 2016

Yes, ACR, national and custom DRLs are supported; segment by age, weight, height, study and series type Web-based protocol management system including Documents radiation dose index on every examination RadLex Master Protocol names, assists with DRLs, produced during CT exam; captures exam speciﬁc dose analysis, benchmarks and automated reporting dose index and summarizes by series or anatomic to speech-recognition, RIS and PACS region; documents dose in a retrievable format, displays performed and scheduled studies Yes, ability to acquire all necessary dose information, calculate additional dose values (ICRP 10360, SSDE), and automate export to patient record and or registry McKesson, Siemens, Philips, Toshiba, Landauer, West Physics

N/A N/A An introductory dose management solution compat- XR-29 dose check and dose report functions ible with select GE CT devices; this easily accessible cloud-deployed Web application provides detailed exam-level dose and protocol information, analytics and reporting

Yes, CT and interventional/cardiac dose tracking, patient and protocol analytics, identiﬁcation of outliers, EMR/RIS/dictation integration

Displays protocol and dose data for GE CTs; data is aggregated, analyzed and summarized within the application to provide insights about practice-level dose performance GE Healthcare is the sole owner of DoseWatch; GEHC GE Healthcare is the sole owner of DoseWatch sells the product directly via internal sales channels Explore; GEHC sells the product directly via internal sales channels Vendor neutral, multimodality software for Multiple connectivity/data acquisition options, e.g. Cloud-deployed Web application, without any IT integrated radiation and contrast dose management DICOM header, MPPS, RDSR, PACS (OCR/DICOM) integration required and no required hardware; and proprietary automatically retrieves, tracks and reports radiation dose for GE CT devices

Yes CTDIvol, DLP, SSDE, ICRP, organ dose, kVp, mAs; CTDIvol, DLP, SSDE, eﬀective and cumulative dose, cumulative (for some metrics), exam and acquisition target region Customizable Name, technique, iterative reconstruction, RPID, RIS, kVp, mA, max mA, pitch, noise reduction, iterative recon, scan length, range, phantom type, exposure time and rotation/single collimation width and total Yes, based on eﬀective diameter or water-equivalent Automatic SSDE per AAPM Task Group 204 diameter (WED)

Yes Series number, CTDIvol, DLP, series type, scan length Yes

2011 Enables ultra low-dose CT scans

Yes

Series number, series description, kV, Auto mA, mA, Max mA, mAs, exposure time, rotation time, pitch, single coll; width, total coll., noise index, % iterative recon No

Yes

Yes, analytics evaluating dose by customizable variables, DRLs, automated alerts, interactive dosimetry tool PACS and/or device integration: data from available DICOM headers, RDSR, MPPS, dose sheet OCR; Certegra Workstation; supports historical data migration via PACS Query retrieve or auto-route DICOM data from PACS and/or device; MPPS from device

Positioning, mA modulation, patient centering and reviewer comments

Yes

Many data collection options: DICOM header, MPPS, RDSR, PACS (OCR/DICOM), HL7, proprietary

Through proprietary GEHC CT scanner Insite connection and CT log ﬁles

Extracting dose information from protocol parameters, dose report images and DICOM tags

Original data is collected directly from medical device, stored and parsed into database tables; can be reloaded if necessary

Data collected directly from the GE CT using Insite connection, stored in the cloud and available thru the Web application

Extracting dose information from protocol parameters, dose report images and DICOM tags

Compression force, entrance dose, image count, kVp, mAs, mean glandular dose (total, left, right) Customizable PACS and/or device integration; data from available DICOM headers; supports historical data migration via PACS Query retrieve or auto-route DICOM data from PACS and/or device

N/S

N/S N/S

N/S

Yes DAP, ﬂuoro time, entrance dose, number of exposures Technique, ﬁlter, exposure, grid, view, DSD, etc.

No N/S

N/S N/S

N/S

PACS and/or device integr; data from available DICOM headers, RDSR, MPPS and dose sheet OCR; supports historical data migration via PACS Query retrieve or auto-route DICOM data from PACS and/or device; MPPS from device

DICOM header, MPPS, RDSR

N/S

Original data is collected directly from the medical device, stored and parsed into database tables; can be reloaded if necessary

N/S

Yes IT analyst, PACS administrator/analyst, others as required

Yes Project manager, technical and clinical specialists

Yes No Project manager, dose leader, applications specialist, Support services, TiP applications specialist medical physicist

Yes Application engineer

What is the support process

Application support is available 24/7 via help desk, phone or e-mail; all U.S. based

Service contract provides onsite and remote support Support services thru the service contract on the GE CT

24/7 by phone and e-mail, problems solved by remote access

Customer time (hours) required to install new modality

Dose information is collected from the PACS, so minimal eﬀort is required to add additional modalities

Scoped per client, oﬀering support packages including VirtualCare; 24x7 remote support for contracted customers Dependent on project scope of work

Each implementation plan is customized and managed by GE project managers

1 hour

2 hours

Mammography Dosimetric information: organ dose (mean glandular dose); entrance skin dose Protocol parameters Data collection method

All DICOM/MPPS

How is dose data transferred into software

PACS or modality

Radiography / ﬂuoroscopy (X-ray) Dosimetric information: DAP

Yes

Protocol parameters

All

Data collection method

DICOM/MPPS

How is dose data transferred into software

PACS or modality

IMPLEMENTATION PROCESS Is there a project manager to manage implementation What vendor roles or personnel are involved in implementation

DOSE DATA What parameters are used to record dose and set alerts

Yes

None

Customized per client’s preference; variety of parameters available for thresholds and alerts

Standard metrics supported; alerts based on CTDIvol, DLP, CTDIvol, mA, kV, scan length, pitch, noise index, CTDIvol, DLP DLP, cumulative dose, scheduled repeats; age, % iterative recon, etc; DLP, CTDIvol, number irrad height, weight speciﬁc events for alerts

CTDIvol, DLP

Do you support eﬀective dose measurements? If so, how is it calculated/ ICRP 103, mSv reported

Yes, eﬀective dose is calculated in mSv for ICRP 103, 60 standards using Monte Carlo simulation

Yes, DLP conversion factors, mSv

How is dose data displayed: plain text, pie chart, bar graph, plot charts, etc.

All, some via export

Plain text

Yes, “click on the dot”

Interactive charts (pie, bar, scatterplot, timeline); tabular; sort and ﬁlter; user roles deﬁne access and visibility Yes, direct links to patient data

Interactive charts (pie, bar, timeline); tabular; sort and ﬁlter

Are chart data points interactive

Dose data displayed by plain text, exam and patient level dose tiles, in various analytic chart types and is fully exportable Yes, data points, bars and axis are interactive

Yes, only data grids

How does software estimate size speciﬁc doses by correcting CTDIvol readings with phantom size (16 cm, 32 cm) and patient eﬀective diameter (ala AAPM 204 mechanics)

Full SSDE support via AAPM 204

Automatically calculate the water-equivalent diameter and eﬀective diameter per acqusition slice and apply AAPM task group 220 methodology to output SSDE

N/S data can be exported for further analysis

Calculated based on existing data

Does system take into account body mass index? If so, how is BMI entered Dose thresholds and warning alerts can be set in system? By modality, overall dose, etc.

Yes, BMI can be calculated from automatic or manually entered data Enterprise, facility, modality, procedure, patient, staﬀ

Yes, if weight and height can be extracted from DICOM or HL7, BMI can be calculated Yes, allows multiple DRLs based on local, registry, protocol spec and percentile-based values

AAPM Task Group 204 lookup tables, speciﬁc to either the 16 cm or 32 cm diameter phantom, are used to determine CTDIvol to SSDE conversion factors; AP, lateral or eﬀective diameter is used based on the available data; AAPM TG 220 methodology will be supported Yes, BMI based on height and weight provided by the device, entered directly or via HL7 connection Thresholds can be manually set, via DRLs or automatically set using the statistical properties

Yes, taken from patient information

Yes, by all parameters

How is dose data displayed

User selectable

Diﬀerent display capabilities at the patient, exam, acquisition,and enterprise level

Plain text

Any system collected parameter can be alerted on

Acq count, DAP, dev index (max), entrance dose, exp index (max), kVp, mAs, reference point dose Customizable

September 2016 | itnonline.com | Imaging Technology News

Thresholds can be manually or automatically set using the statistical properties of your exams, DLP, CTDI, number irradiation events Interactive charts (pie, bar, scatterplot, timeline) and Interactive charts (pie, bar, timeline) and tabular tabular data supported, w/ ﬁlter, sort opt data are supported, with ﬁlter and sort options

Comparison Chart Compiled by Imaging Technology News Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart. Editor’s Note: All submitted information also appears on our website at www.ITNonline.com. Novarad

PACSHealth

Philips Healthcare DoseWise Portal Class 1 MDDS exempt

NovaDose 2012

DoseMonitor 2012

2013 Automated ionizing dose data collection, reporting and analysis solution

Patient, study, modality and facility

CT, XA, DR and MG

CT, XA, DR and MG, NM, PET

Yes

Yes, will export patient dose data to the EMR via integration with leading dictation softwares

N/A

Feature set, ease of use, straightforward implementation

N/A = Not applicable N/S = Not speciﬁed

ScImage Inc. PICOM365 2000

2016 A vendor-agnostic and multimodality Webbased solution that collects, measures, analyzes and reports patient and staff radiation exposure, assisting healthcare providers to take control of quality of care, efficiency, patient and staff safety

Pending Provides support for dose monitoring by collecting exposure data from the diagnostic modality contained in the metadata (DICOM tags) of each series or image; the dose information is captured and databased within PICOMAnalytics providing comprehensive dose monitoring reports Patient dose is monitored directly from the imaging Dose is captured from DICOM tags of each image modalities to capture all exposure events, not within a series, and cumulative dose is calculated just those sent to PACS; all dose-related DICOM information is captured All X-ray modalities can be monitored including All modalities that embed dose within DICOM, CT, fluoroscopy, DR and mammography incl: CT, angiography, mammography, fluoro, DR Yes, has the capability to set custom DRLs at the ScImage Diagnostic Reporting supports DRL by exam level; software will show exams that have color highlighting levels out of range exceeded the DRL in real-time making the data review process easy for healthcare providers Yes, has the capability of setting a custom Supports DRL by highlighting levels out of pediatric age and DRLs pediatric-specific, customer modifiable, preset ranges Has a robust capability to easily create custom Dose Monitoring reports generated by graphs and charts related to Joint Commission PICOMAnalytics support compliance with Joint requirements, and then save them to a dashCommission board; these dashboards will continue to collect data for reporting and analysis automatically

Sectra

Siemens Healthineers VolparaDoseRT Class 1

Volpara Solutions Inc. VolparaAnalytics Class 1

Sectra DoseTrack 2013

teamplay N/A

2013 Complete solution to automatically collect, store and monitor radiation dose delivered to patients from imaging procedures; allows in depth ad-hoc and automatic reporting to patients, physicians and department managers

N/S Class 1 Displays dose multi-OEM, multimodality sliced Patient-speciﬁc dose that accounts for by scanner, protocol, operator provides box personal breast density view with easy outlier identiﬁcation

Class 1 Patient-speciﬁc dose from Volapara Density

Series, study, patient, room department, site, hospital, region, operator, equipment make, model, type

Modality, scanner, location, operator

Image level monitoring

Any modality; CR, DX, RF, XA, CT, NM, MG

All X-ray-based

Mammography, breast tomosynthesis

Set locally, by exam type, adult/peds and body habitus; the system also allows national and dynamic DRL calculations to occur

Both regulatory and local

N/A

Yes

Yes, set on protocol

N/A

Integration to external registries, such as the ACR; integration to voice reporting systems; the solution is able to publish the patient dose as well as patient imaging historic doses, to third party systems via API and URL integrations

Supports requirements

N/A

ScImage developed dose monitoring to comply with state mandates ﬁrst introduced in Calif. and Texas

Yes

Patient view under development

N/A

Philips manufactures and sells the DoseWise Portal

Carestream Vue Cardio PACS

N/A

Siemens

GE, Siemens

N/A

Dose management solution that combines realtime staﬀ radiation exposure and patient data

For reading physicians, the solution is automated An eﬀective method to interrogate the data at and simple; dose is displayed in the worklist, so a high and low level with ease; the solution is it is easily dictated into the DX report SaaS-based model

All including CTDIvol, DLP, SSDE, effective dose All including CTDIvol, DLP, SSDE, effective dose, Captures CTDIvol, DLP, SSDE and calculate organ specific dose effective dose (mSv) All All All CT machine DICOM outputs such as kV, effective mAs, pitch, width, etc.

Cumulative dose

Easy to install and set-up, low TCO, immediate Patient-speciﬁc dose that accounts for availability of additional features, and short personal breast density release cycles

Patient-speciﬁc dose that accounts for personal breast density

Sectra DoseTrack supports CTDIvol; DLP; SSDE; ef- DLP, CTDIvol fective dose; cumulative dose; target region dose Yes No

N/A

Calculates SSDE using water-equivalent diameter N/A method recommended by AAPM TG220 using patient surview and associated correction factors Data quality review on proper patient positioning, N/A outlier analysis and a intuitive reporting tool

Yes

Yes, WED

N/A

Yes

N/S

N/A

Yes

RDSR, DICOM header, OCR

RDSR, DICOM header, OCR, proprietary dose estimation

Data is collected directly from the machine via RDSR, MPPS, OCR image capture and may be collected remotely via the EMR/PACS

Dose data is collected from DICOM tags as study is processed before archived to ScImage PACS

DICOM dose SR, MPPS, OCR of CT secondary capture image, HL7, PACS Q/R integration (DICOM headers), manual entry

Automatic collection from PACS

N/A

DICOM

Dose data is transferred via a DICOM node LAN connection between the CT machine and DoseWise Portal and uploaded into a SQL database

Dose data is stored in SQL database, can be automatically mapped to reports and exported via HL7

The dose is received using any of the methods in line 20; this is received by the locally deployed proxy/gateway service which encrypts the data and transmits it to the datacenter

RDSR, patient protocol

N/A

Yes

Mean glandular dose

Yes

All DICOM/MPPS

Yes DICOM Dose SR, MPPS, HL7, PACS Q/R integration, manual entry

No RDSR

Patient-speciﬁc dose that accounts for personal breast density Any DICOM image analysis

PACS or modality

Yes N/A Data is collected directly from the machine via DICOM RDSR, MPPS, OCR image capture and may be collected remotely via the EMR/PACS Dose data is transf via a DICOM node LAN conn btwn the DICOM machine and portal and uploaded into a SQL database

Patient-speciﬁc dose that accounts for personal breast density Any DICOM image analysis

DICOM Dose SR, MPPS, HL7, PACS Q/R integration, manual entry

Automatic from PACS

Dose data is derived from DICOM header and pixel data

Yes

N/A

Yes

All

N/A

Yes

N/A

Yes

DICOM/MPPS

DICOM

DICOM Dose SR, MPPS, HL7, PACS Q/R integration, manual entry

RDSR

N/A

Yes

PACS or modality

Yes, DAP is captured by the DoseWise Portal via the machine Yes, all machine operating parameters are collected via DICOM such as collimators and mA at the event level Data is collected directly from the machine via RDSR, MPPS, OCR image capture and may be collected remotely via the EMR/PACS Dose data is transferred via a DICOM node LAN connection between the machine and portal and uploaded into a SQL database

DICOM

The dose is received using several methods; this is received by the locally deployed proxy/ gateway service which encrypts the data and transmits it to the datacenter

Automatic from PACS

N/A

Yes IT analyst, PACS administrator/analyst and others as required

Yes A Philips project manager, software engineer, ﬁeld service engineer and clinical applications specialist will be involved in the process Philips will provide remote technical support as needed from 8 a.m. to 5 p.m. EST

Yes ScImage with no third Party involvement

Yes Sectra project manager, Sectra technical manager and Sectra engineers

No needed, available for support Local IT admin

Yes PACS, IT, radiology management, breast imaging management

24/7 helpdesk, onsite and remote support as needed

Customer has access to the Sectra helpdesk 24/7 Online, phone

Web, e-mail, telephone, on-site

Dose information is collected from the PACS, Dose information is collected from the PACS, New imaging modality equipment can be so minimal eﬀort is required to add additional so minimal eﬀort is required to add additional connected via a DICOM node which takes modalities modalities approximately 15-20 minutes

Approx 0 - 0.5 hr per modality

1-2 hours

Install in less than an hour

Depends on conﬁguration complexity

Any system collected parameter can be alerted on

Yes, common dose attributes may be used to record dose and set alerts such as DLP, SSDE (WED), CTDIvol, DAP, CAK, EDE, etc.

ScImage records all dose data in DICOM metadata; alerts are conﬁgured in PICOM Structured Reports

DLP, CTDIvol

DICOM radiation dose SR, conﬁguration

ICRP 103, mSv

Proprietary algorithm based on breast density

N/A

All, some via export

Yes, eﬀective dose is calculated and available in the patient summary screen using current industry standard dose conversion factors Dose data is displayed using spark lines, histograms, box plots and scatter plots

Bar, box, grid

N/A

All

Yes, “click on the dot”

Full SSDE support via AAPM 204

Yes, BMI can be calculated Enterprise, facility, modality, procedure, patient, staﬀ

Yes, BMI can be calculated from automatic or manually entered data Enterprise, facility, modality, procedure, patient, staﬀ

BMI is an available metric to be used as a factor in data analysis and is captured through the EMR System alerts and thresholds may be set by any number of custom factors including dose

If custom formula in PICOMSR, BMI from patient Ye,; BMI can be entered automatically by the record is used, else uses what modality supplies modality, via the user interface or via HL7 Modality level measurement. PICOMSR will Yes display highlighted values if exceed thresholds

User selectable

Dose data is displayed using standard and custom graphs, charts and tables

Displayed in plaintext within column of worklist

Application support is available 24 x 7 via help Application support is available 24/7 via help desk, phone or e-mail; all U.S.-based desk, phone or e-mail; all U.S.-based

Any ﬁeld within the database can be used to trigger an alert; these range from the obvious dose indices such CTDIvol, DLP, CAK, DAP, AGD, etc. Yes; PICOM Structured Reports and PICOMAna- Yes, it is calculated using Monte Carlo algorithms lytics support custom formulas/calculations based on 3-D deformable phantoms matching using on dose data in DICOM body habitus HTML, Excel or plaintext; PICOMAnalytics reports The system uses all of the methods described as include bar graphs and plots well as scatter and diagrammatic representations of the data No Yes

Yes, chart data is interactive where the user can drill into data points anywhere in the display Yes, the Philips SSDE method uses methodology Modality level measurement outlines in AAPM TG 220 including waterequivalent diameter 16 cm and 32 cm phantoms using the patient’s CT scout/surview image as a reference in body mass

Yes

Dose data is displayed in a tabular, graphically where most appropriate

Yes

N/A

WED

N/A

Out of RDSR or header

N/A

Yes

N/A

Breast only

Bar, box, grid

DICOM SC, radiation dose SR

Web interface

Imaging Technology News | itnonline.com | September 2016

INFORMATION TECHNOLOGY

Electronic Medical Records

Three Beneﬁts of

EMR Imaging Integration EMR integrations are key to simplifying operations and streamlining workƪow with existing systems By Erin Martin

rom streamlining your workflow to maximizing your return on investment (ROI), there are numerous benefits to having image integration with your electronic medical record (EMR). Below are three EMR integrations found to be very helpful to imaging centers. 1. Electronic Receipt of Orders from Referrers Much like a game of telephone, a lot can get lost in translation between the referrer and the imaging facility when sending and receiving orders. That is why it is important for your referrers to have a way to send electronic orders with the exam description, diagnosis code(s), notes, insurance information and prescription directly to your EMR. This gives your schedulers and eligibility verification staff all the information needed to verify eligibility and to obtain pre-authorization from insurance carriers, so your patients and referrers can rest assured knowing your team has what it needs to get authorization for requested exams. Some vendors offer electronic orders as part of their EMR, which enables referrers to login to the EMR and send messages directly to imaging center staff (similar to e-mail, but part of the EMR). Others may only offer a way to integrate with your referrers via HL7, JSON or an API. JSON and APIs do not require a VPN to secure your data. Some HL7 interfaces can utilize HTTPS to transfer your data, which also eliminates the need for a VPN between systems, while keeping your patient data secure. 28

September 2016 | itnonline.com | Imaging Technology News

2. One-Click Integrations Whether your picture archiving and communication system (PACS) can send a link to your referrers’ EMR, enabling them to launch images in PACS with a single click for open access imaging, or if you’re using an XML integration that launches another software for dictation, reporting, mammography tracking or billing for a streamlined workflow, one-click integrations will simplify your workflow. No more searching two separate systems to bring up the correct patient and exam — just one click launches what you need from your EMR or integrated vendors. EMR integration is not just about HL7 anymore. There are so many ways XML can work with HL7, JSON or APIs to maximize efficiency and simplify life for all your employees.

3. Good Ol’ HL7 EMR Integrations Almost all vendors support HL7 for EMR integrations. If they don’t, then I would be hesitant to use their software, unless they really do oﬀer everything you need so there is no reason to integrate with another vendor. However, I have yet to meet an EMR that oﬀers everything for all specialties and roles (from billing to mammo tracking to reporting) perfectly integrated onto one server. It is not an easy feat

to integrate all aspects a healthcare facility needs onto one server, so I am certainly not judging or condemning software vendors for not yet offering this solution. HL7 improves workflows by allowing data to flow in and out of your EMR. This data flow reduces data entry errors, decreases data entry time, improves efficiency, cuts costs and generally leads to happier administrators, since they no longer have tons of corrections to make and paperwork to chase down. It is true that if one of the integrated systems goes down, headaches can ensue, but you can always fall back on your old workflow prior to your EMR integration. Until an all-in-one EMR comes to the market and healthcare facilities have unlimited budgets to purchase it, EMR integrations are the key to simplifying operations and streamlining workflow with the systems you are already working with. Investing in EMR integration is worth the return with the hours your staff will save on correcting data entry mistakes and the increased referrals you will receive from running a more efficient practice. itn Erin Martin is a senior integration specialist at RamSoft Inc.

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BUSINESS

Clinical Decision Support

CDS as a

Trusted Resource How intelligent clinical decision support reduces medical errors and drives value

By Ami Mayo, M.D.

n May 2016, the British Medical Journal (BMJ) published a startling statistic. The prestigious journal pegged medical error as the third-leading cause of death in the United States. Because medical error reporting is not well-tracked, the paper’s authors needed to scour the medical literature and extrapolate the incidence of errors based on the best available data. The authors analyzed information from multiple reports on the subject, including a 1999 Institute of Medicine (IOM) report, a 2004 HealthGrades quality study and a 2010 report by the Department of Health and Human Services (HHS). After analysis, the authors cited a rate of medical errors of 1.13 percent, or over 400,000 deaths per year. In publishing this analysis, the BMJ authors hoped to open a dialogue about how to collect medical errors data, categorize it and, most importantly, prevent errors from occurring. To achieve this objective, the authors advised developing a strategy that includes “making errors less frequent by following principles that take human limitations into account.” Indeed, even the best-trained physicians are not infallible. Human error may never be entirely avoidable, but today’s clinicians have more tools than ever at their disposal to help overcome their fallibility. In fact, technology is increasingly aiding physicians by serving as an extension of their own memory and clinical acumen. The current era of medicine has seen a huge rise in technology usage, from computer-assisted surgery to the advent of electronic medical records (EMR). The next logical step for integrating technology into the practice of medicine lies in advanced clinical decision support (CDS) software. This technology can reduce the incidence of medical errors that result in patient harm by aiding physicians in recalling and analyzing data while leveraging industry best practices. Beyond this crucial functionality, CDS oﬀers additional beneﬁts, including improved patient care and enhanced value.

Reducing the Rate of Medical Errors

and measurements within an EMR can sometimes be diﬃcult and time-consuming, requiring 10 mouse clicks or more to access said data. Unfortunately, important free text notes are often missed by clinicians because the data cannot be accessed, read or understood by the EMR. In fact, information documented by radiologists is oftentimes stored in the notes section as unstructured data, which are not easily captured and read by most CDS programs. Data that cannot be accessed contribute to an incomplete clinical picture, and raise the possibility for medical error. Advanced CDS technology helps avert errors by capturing important and relevant data needed by the clinician — including clinical details from ambulatory EMRs and ancillary systems such as labs and radiology departments. Having the full clinical picture enables the physician to accurately assess both the patient’s current and past complete clinical proﬁle, and ultimately order the correct required medications, tests, procedures and interventions. Systems that alert clinicians to crucial structured and unstructured information in the EMR are imperative to avoid errors, duplicate studies or reduce potentially harmful events. In this way, advanced technology functions as an extension of the clinician’s own skills and judgment in order to analyze the patient’s condition and appropriately intervene as necessary.

Radiologists and other clinicians rely on the accuracy of data to inform their decision making. Enormous amounts of information contribute to diagnosis and treatment processes — from a patient’s most recent blood pressure reading to the lung lesion ﬁrst detected on imaging tests three years prior. However, too often vital information is lost or not fully captured within the EMR. Finding speciﬁc data

“This technology can reduce the incidence of medical errors that result in patient harm by aiding physicians in recalling and analyzing data while leveraging industry best practices.”

September 2016 | itnonline.com | Imaging Technology News

For radiologists in particular, a primary beneﬁt of advanced CDS is its ability to assist in adhering to best practice guidelines, as following evidence-based best practices can help reduce medical errors. Because advanced CDS software programs continuously read and analyze the patient record, CDS can alert radiologists, for instance, to data that can inform imaging orders. An advanced CDS program might prompt a radiologist to choose a low radiation dosage for a study, based on best practice guidelines and speciﬁc clinical information in the EMR indicating the patient has had multiple studies within a relatively short period of time. Without this data, the radiologist could expose the patient to unnecessary radiation, which could have been avoided.

Overcoming Data Overload While it’s true that clinicians rely on data to inform their decision-making today, the sheer volume of data can be overwhelming. Doctors are bombarded with complex information at every click and turn, which can make it diﬃcult to remember every detail required to deliver high-quality patient care. If a critical data point isn’t available at the point of care, a medical error may result. For example, consider, per protocol, that a radiologist phones to relay information to an attending physician. However, the physician at

Improving Patient Safety Beyond reducing medical errors, advanced CDS technology can improve patient safety in other ways. As advanced CDS continuously reads and analyzes all of a patient’s health data in real time, this technology can identify trends earlier than the clinical eye may detect them. As Machiavelli wrote in 1513, “Hectic fever at its inception is difficult to recognize, but easy to treat. Left untreated, it becomes easy to recognize but difficult to treat.” Today’s medical clinician can rely on CDS to help peer into the future and recognize “hectic fevers” and more. Think about the patient in the ICU who appears to be stable but is, in fact, brewing pneumonia. Before the patient exhibits overt signs of sepsis, advanced CDS, with its ability to read vital signs and lab trends, is programmed to alert clinicians to subtle clinical changes indicative of infection. Armed with this reliable data, the clinician can initiate sepsis protocol early and successfully treat the patient before the situation becomes critical. For instance, an early diagnosis of pneumonia leads to initiating early treatment, when it benefits the patient more and costs less. And, consider adverse reactions. Perhaps a patient had a serious adverse reaction to CT contrast medium five years prior. Since the reaction did not represent an allergy per se, the information may not be presented in the EMR. In fact, this event may be recorded only in a historical, free text note that is inaccessible, or buried in the current patient record. A busy clinician may not see this note at all — despite careful review of the patient record that could possibly lead to an error and a serious adverse event. However, advanced CDS technology can proactively call this information to the clinician’s attention at the moment a CT with contrast is ordered, ensuring patient safety.

PHOTO COURTESY OF CARESTREAM

the time of the call is with a patient. Receiving the radiologist’s report, the clinician jots a note and returns to the patient. By the time the physician sees the patient the radiologist called about, hours or possibly days have passed and the radiology report is inadvertently overlooked. Without the radiologist’s important input, a medical error could occur or an imaging study could be duplicated. Furthermore, the study would not be reimbursed by the payer since its necessity is not supported by the clinical record. Advanced CDS can salvage this situation by accessing and understanding, in context, the radiology report. The CDS calls attention to the discrepancy at the precise moment it becomes relevant. When the physician logs on to the patient’s EMR record to order a duplicate study, the CDS solution generates a visual alert on the EMR screen — reminding the clinician of the previous ﬁndings. The CDS, in real time, advises against the duplicate imaging study, and the physician is prompted to re-read the radiology note. The result: The doctor orders a less-invasive diagnostic test, a medical error is averted and delivery of care is back on track.

Another common example to consider is when a patient chart contains notes from a provider that the clinician is unaware the patient has seen. Clinicians would not know to search for a note that they did not know existed. One example of such an instance is the case of a patient who presents with a persistent cough of duration greater than three months. The patient is a smoker. She neglects to mention that six months prior, she received a chest X-ray from a diﬀerent provider within the same healthcare system and for the same complaint. The current physician attempts to order a chest X-ray, but an advanced CDS alerts the clinician about the previous study and the subsequent ﬁnding of emphysema. Now, fully informed with the complete clinical picture, the physician withdraws the order for a duplicate imaging study. Another example of technology helping to improve patient safety by intervening is seen in the case of a patient who presents “emergently” with an altered level of consciousness. The physician may initially think “stroke” and order a head CT. As the scan result is generating, the physician proactively begins to order tPA, per protocol. The CDS solution alerts the provider of radiology notes indicating a “hemorrhagic stroke,” not a clot, and a potentially catastrophic medical error is averted.

Driving Value on Multiple Fronts Reducing medical errors first serves to protect patient safety, but it also has the effect of simultaneously driving value, as medical errors generally result in costly interventions or lost reimbursements. Because an advanced CDS system can reduce the incidence of errors and enable clinicians to confidently initiate early treatment, CDS can be said to drive value on multiple fronts. Another way the technology enhances value is by reducing the number of unindicated, unreimbursed studies that occur within a healthcare system. Advanced CDS guides clinicians in choosing the most appropriate studies for each patient, thereby establishing the medical necessity of each study. Documented indications lead to improved patient safety and higher reimbursement rates.

Finally, advanced CDS enhances value by meeting the Medicare requirement for radiology use of CDS by Jan. 1, 2017, in order to receive maximum reimbursement. This requirement will likely be pushed back to 2018 or beyond since federal guidelines for CDS software have not yet been developed.

Intelligent CDS Improves Clinician Partnerships In addition to advanced technology reducing medical errors, improving patient safety and driving value — CDS enhances clinical partnership between varying medical specialties. For instance, with advanced CDS technology, radiologists can be confident that their notes will be captured, read, understood and incorporated into the patient profile and diagnosis instead of being inaccessible in the EMR. This type of technology makes it possible for radiology reports to be available to clinicians in real time and at the point of care to better inform highly accurate decision-making. When clinicians are in receipt of accurate radiology data, they can eliminate unnecessary studies and tests, thereby reducing the possibility of patient harm through adverse events or complications. As the medical profession works to prevent costly medical errors, it needs to incorporate technology, including advanced CDS, to provide accurate, pertinent information and prompts without workflow interruption. As such, advanced CDS is poised to become a trusted resource for radiologists, neurologists and cardiologists, as well as other specialties. itn Ami Mayo, M.D., chairman of medCPU’s medical department, has more than 25 years of clinical experience in surgery and critical care medicine. His medical career has focused on emergency surgery, and management of the most complicated trauma and surgical patients in need of critical care. He has practiced in major Israeli hospitals and been involved in medical research focusing on disaster medicine, disaster preparedness, multi-dimensional injury patterns of blast trauma, critical care in extreme scenarios, sepsis management, coagulopathy in the trauma patient and surgical education. Imaging Technology News | itnonline.com | September 2016

WOMEN’S HEALTH

3-D Tomo

3-D Digital Breast Tomosynthesis:

Still Going Strong The DBT market continues to thrive as facilities update older systems with this technology By Rachael Bennett, BHS, R.T.(R)(T) and Julie Johnson

efore the introduction of 3-D digital breast tomosynthesis (DBT) imaging, 2-D full ﬁeld digital mammography (FFDM) systems were the gold standard for breast cancer screening. However, during the past few years, DBT has become the new gold standard. Every major vendor within the mammography market either has a viable DBT solution or is in the process of obtaining U.S. Food and Drug Administration (FDA) clearance. In spite of concerns about increased radiation dose and higher price points for the technology, interest in 3-D tomosynthesis is still going strong. With the growing number of DBT solution options as well as the continued clinical evidence supporting this technology, it is no surprise that most women’s imaging centers either have or plan to purchase this technology. Consistent with previous purchasing trends throughout the past several years, the market analysis ﬁrm MD Buyline seldom evaluates a purchase for a system that is not 3-D tomosynthesis capable.

Breast Density and DBT Some readers may wonder at the inclusion of breast density in conversations about DBT. Breasts are made of breast tissue, connective tissue and fat. Breast density is a measurement of the breast and connective tissue to fat ratio. Women with more fat than tissue are considered to have low-density breasts, and women with more tissue than fat are considered to have high-density breasts. Breast density can also change over time; younger women tend to have denser breasts. So why is this important in mammography screenings? Breast density is a signiﬁcant factor for radiologists to consider when reading the images of a mammography exam because these studies are often harder to interpret. On a mammographic image, fat in the breast appears dark, and tissues are either light gray or white. However, cancerous areas are also white. Because dense tissue can mask cancer, breast cancer in women with dense breasts has the potential to go undetected. With the introduction of DBT, the likelihood of a cancer going undetected is much lower. Unlike a ﬂat 2-D FFDM image, DBT takes a series of images similar to a computed tomography (CT) scan, which allows radiologists to visualize individual slices of the breast 32

September 2016 | itnonline.com | Imaging Technology News

and identify abnormalities that would have been obscured on FFDM images. It is not only radiologists and technologists who are noticing the positive eﬀect of this technology. Patients also notice the diﬀerence. We continue to hear of patients who are accustomed to receiving a dreaded callback for a follow-up procedure due to a suspicious area on their FFDM images. However, when they receive the DBT study instead, the phone seldom rings because DBT is better able to visualize the areas of suspicion and eliminate the need for a callback visit. These patients are ecstatic that they no longer have the burden of the yearly worry of possible breast cancer.

anticipated the submission of the remaining modules would occur within the next year, which was correct. On July 22, 2016, Fujiﬁlm submitted its ﬁnal module for PMA approval of an add-on tomosynthesis solution for its Aspire Cristalle system. At the time of this publication, the solution is still pending FDA approval.

Market Overview

GE. GE gained FDA approval for the SenoClaire tomosynthesis option in September 2014. SenoClaire is an add-on feature to existing Senographe Essential and Senographe Care platforms. Although GE is considered a competitive vendor in this space, as with other vendors, its late arrival to the DBT market has created a challenge in gaining market activity.

Last year, GE and Siemens received FDA approval and joined Hologic in the 3-D digital breast tomosynthesis market. At that time, Fujiﬁlm Medical

Hologic. Receiving FDA approval in 2011, Hologic was the ﬁrst to introduce tomosynthesis

“Every major vendor within the mammography market either has a viable DBT solution or is in the process of obtaining FDA premarket approval.” had submitted its first FDA premarket approval (PMA) module for its own tomosynthesis solution. A lot can change in a year, so below is a quick update. Fujifilm Medical. On Nov. 14, 2015, Fujifilm Medical announced the submission of its second module for PMA approval. At that time, Fujifilm

imaging to its mammography line of products. Since its introduction of the Selenia Dimensions Tomo, Hologic continues to provide enhancements to its DBT technology. Already a strong presence, this new technology helped Hologic gain an even stronger hold on maintaining its status as the market leader.

MD BUYLINE MAMMOGRAPHY MARKET ACTIVITY

Siemens. The FDA granted approval for Siemensâ&#x20AC;&#x2122; True Breast Tomosynthesis in April 2015. This solution is an upgrade to Siemensâ&#x20AC;&#x2122; existing Mammomat Inspiration and Mammomat Inspiration Prime systems. In May 2016, Siemens announced that it was the ďŹ rst vendor to receive FDA approval to use its 3-D image as a stand-alone screening option. This further proves that the tomosynthesis image is superior to 2-D imaging. Like GE, Siemens is still working to gain market activity after a delayed entry into the U.S. DBT market.

Associated Technologies 2-D synthesized imaging. Although clinical evidence continues to support the beneďŹ ts of 3-D mammography over 2-D imaging, increased radiation dose is still a concern. During a typical 3-D exam, both a 2-D and 3-D image is obtained, contributing to the issue of higher exposure rates. To combat these concerns, a solution has come with the development of 2-D synthesized imaging. 2-D synthesized imaging reconstructs a 2-D image from the 3-D dataset. Both the 2-D and 3-D images are read together. This replaces the need for acquiring a 2-D image during the exam. The 2-D images are labeled as synthetic images, not to be mistaken for true 2-D digital images. Clinical studies have shown that the combination of the 3-D exam in conjunction with a 2-D synthesized image provides a higher level of image quality than a standard 2-D digital mammography exam alone. Thus, the patient receives the advantage of a 3-D exam with a lower exposure rate, better level of comfort and reduced exam time.

Hologic is currently the only company that oďŹ&#x20AC;ers 2-D synthesized imaging in the U.S. with its C-View oďŹ&#x20AC;ering. GE and Siemens both oďŹ&#x20AC;er 2-D synthesized imaging products available in Europe. Siemensâ&#x20AC;&#x2122; Insight 2-D synthesized imaging is currently pending FDA clearance. Biopsy systems. Although DBT is a game-changing technology, the advanced imaging features created some challenges for breast biopsies, speciďŹ cally those performed on prone biopsy systems. When DBT ďŹ rst came to the market, prone biopsy systems still used FFDM technology. This meant that a patient could have a DBT study that identiďŹ ed a suspicious area, but when the patient was taken to the prone biopsy system for further evaluation, the FFDM image was not advanced enough to identify the original suspicious area seen on DBT. To combat this challenge, a large portion of centers opted for an add-on upright biopsy system. This way, they could use the same system to acquire the original image and perform the biopsy without any diďŹ&#x20AC;erences in image quality. However, on April 23, 2016, Hologic announced FDA clearance of the AďŹ&#x192;rm Prone Biopsy system. This system allows the comfort of a prone table with the 3-D imaging capabilities of the mammography system. Since its introduction, MD Buyline has seen a signiďŹ cantly increased interest in prone biopsy systems.

Clinical Evidence There have been numerous notable studies proving the advantages of DBT, including the Journal of American Medicine Associationâ&#x20AC;&#x2122;s (JAMA) study released in June 2014 and the MalmĂś

Breast Tomosynthesis Screening Trial published in April 2015. More recently, a research article featured in the Bosnian Journal of Basic Medical Sciences in August 2015 noted that DBT not only is superior in detecting and characterizing breast lesions to FFDM, but also is superior to breast MRI.

Looking Ahead Based on MD Buyline activity and customer feedback, we continue to see increased interest in DBT technology. We anticipate that it will continue to thrive as imaging centers replace older systems with this groundbreaking technology. itn Rachael Bennett joined MD Buyline in 2008 with seven years of clinical experience in the medical ďŹ eld. She is the primary clinical analyst for linear accelerators, stereotactic radiosurgery, mammography systems, biopsy systems and other radiation oncology and womenâ&#x20AC;&#x2122;s health capital equipment. She currently holds registries as both a radiographer and radiation therapist through the American Registry of Radiologic Technologists (ARRT). Prior to joining MD Buyline in 2008, Julie Johnson worked in account management, accounting and ďŹ nancial planning. At MD Buyline, she serves as an analyst, providing support to the clinical analysts and helping MD Buyline members make informed purchasing decisions. Johnson supports the teams for neurology, radiology, OR, linear accelerators, stereotactic radiosurgery, mammography systems, biopsy systems, radiographic systems, portable radiographic systems, ďŹ&#x201A;uoroscopy and computed radiography capital equipment codes. Imaging Technology News | itnonline.com | September 2016

the last read

Greg Freiherr

How Radiology Can Put The Patient First

adiology cannot stay where it is. Yet threats make it dangerous to move.

GRAPHIC COURTESY OF PIXABAY

According to a 2015 report by the Identity Theft Resource Center, cyber breaches at healthcare institutions represented about one-third of such reported incidents nationwide.

The adoption of picture archiving and communication systems (PACS) and electronic medical record (EMR) systems has increased healthcare’s vulnerability to cyber attack. According to a 2015 report by the Identity Theft Resource Center, cyber breaches at healthcare institutions represented about one-third of such reported incidents nationwide. The widening adoption of enterprise imaging could make healthcare even more vulnerable. Quantitation promises objectivity, but threatens to restrict the human element of decision-making, pulling radiology further back from patient involvement. Radiologists are being urged to become more involved; to exert greater influence in the management of patients. But doing so runs counter to what radiologists traditionally have done. Radiologists have, for the most part, been a kind of human black box. Images are read; conclusions are drawn and dictated. With the exception of interventional radiology, patient contact has been limited. Some pundits in radiology have proposed that radiologists become more patientoriented to better fit the growing emphasis on patient centricity in value medicine. But that’s like saying a lion should become a zebra because stripes are “in.” If radiologists veer down this path, they could risk their sense of self. Decades of service have established them as experts at interpreting medical images and advising other physicians — conveying to them the significance of clinical findings. Radiologists don’t have to change. Their skills can continue to serve them — and patients — well. Those skills just have to be fitted into the evolving character of value medicine.

Eliminating The Draper Effect To gain influence among other specialties, radiologists could adopt the role of guardians of truth, pushing back against the “Draper Effect” — that button-down, crisp white shirt, straight tie, shoes shined to a gloss perfection, which in commercialized radiology takes the form of “perfect” images. They are prevalent at trade shows; appear commonly in sales brochures; and accompany case studies on vendor websites. Draper images are spectacularly unreal, and as such rub against the grain of value medicine. If radiologists were to fight against them, it may be a very good thing. Not only will it amplify the credibility of radiologists, but the true validity of imaging technology. Nothing undoes a technology or, by extension, a product, like disappointment. And disappointment is sure to happen if practitioners expect to get these pristine beautiful images when the everyman and everywoman is scanned, especially when efficiency and effectiveness are premiums. Radiology can enhance its influence in healthcare through the balanced and thoughtful inclusion of

September 2016 | itnonline.com | Imaging Technology News

technologies, calling upon their experience and knowledge to help facilities come up with policies about when and how to use imaging technologies. This will be especially so when new imaging technologies and capabilities are considered — for example, quantitation. Quantitation may appear ready-made for value medicine with its emphases on efficiency and cost reduction. At the University of Pennsylvania, the Penn Center for Innovation has developed an image quantification tool that promises to help achieve both goals. Called the Automated Anatomy Recognition (AAR) system, it localizes and delineates cancer in multiple body regions using magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET)/CT images. When applied to radiation therapy planning, AAR can reduce the time needed to delineate organs from several hours to less than five minutes.

The Perils of Modern Imaging But quantitation, which by definition associates a range of numerical values with a certain pathology, may create the illusion that diagnosis can be reduced to numbers. And that is just not true. When interpreting exams, radiologists draw from their experience. They may consider quantitative measures, but they will be interpreted in a broader context, one that involves qualitative measures. Being the voice of caution, when it comes to the adoption of technologies and their routine use, requires careful consideration. Through PACS, radiology paved the way for healthcare’s transition to electronic medical records. As digital information makes new inroads, leveraging enterprise imaging, radiologists are well positioned to provide the vigilance and insights to defend the integrity of healthcare. This is particularly so when it comes to cyber threats. The world is awash in hacking, from politics to finance. Even government agencies, which should have the strongest defenses, seem powerless to stop incursions. Instances in healthcare are revealing vulnerabilities that radiology can — and must — battle. Particularly vulnerable are networked imaging devices that use outdated operating systems, such as Windows XP, non-patched versions of Windows 7 and 8, and Windows NT. By leading through example and fighting to remedy these problems, radiology can point the way to a safe and wise use of medical technologies.

The Path Ahead It is imperative that radiology move forward, building upon its past to make a stronger future, and resisting efforts to “put patients first” in the same ways as do family practitioners, sports medicine specialists and oncologists. Radiologists can put patients first in ways that build on the strengths of their profession, strengths established over decades of practice, serving as the arbiters of technologies and clinical results; working with other physicians to manage and protect patients; and leveraging skills that have come from understanding and meeting the needs of patients … as only radiologists can. Editor’s note: This column is the culmination of a series of four blogs by industry consultant Greg Freiherr on Patient Centricity. The blogs, “Value Medicine: Radiology’s Big Chance,”“What To Do About The Draper Effect,”“The Case Against Quantitation” and “Protecting Patients From Hackers,” can be found at www.itnonline.com/content/ patient-centricity.

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