Experts See Integration of Imaging Biomarkers by 2025

It took the 50 experts who gathered for the second RSNA-sponsored Imaging Biomarker Roundtable just a day-and-half to create an overarching vision for 2025—a plan that includes establishing a valid and accurate collection of quantitative imaging biomarkers that are seamlessly integrated into clinical practice and trials.

Creating the vision may have been easy, but it will take considerably longer to strategize the roadmap needed to put the plan into motion, said facilitator and keynote speaker David M. Dilts, Ph.D., M.B.A., director of clinical research at the Knight Cancer Institute at Oregon Health & Science University in Portland and a professor of healthcare management at the university.

Participants at the roundtable held in Rosemont, Ill., in March included a diverse mix of representatives from academic institutions, professional societies, pharmaceutical and device manufacturers and government organizations who vowed to continue their coordinated effort to help shape the future of imaging biomarkers. An RSNA-sponsored follow-up roundtable session is tentatively scheduled for July 9–10 in Chicago.

"Today is the tip of the iceberg toward roadmapping," said Dr. Dilts. "We're doing this top-down as opposed to bottom-up. We want to know what the world of biomarkers should look like in 2025 and then go backward and figure out the best way to get there."

RSNA organized its first biomarkers roundtable in 2008 to bring together experts who share a considerable stake in the coordinated progression of the field but have little communication with each other, said Daniel C. Sullivan, M.D., RSNA Science
Advisor and chair of the RSNA Research Development Committee. RSNA remains committed to establishing radiology's role in the personalized medicine revolution by facilitating imaging as a biomarker in clinical trials and helping transform radiology from a qualitative to quantitative science, Dr. Sullivan said.

"What grew out of that first meeting was a sense that everybody thought that some higher level of coordination would be desirable," said Dr. Sullivan, a professor in the Department of Radiology at Duke University in Durham, N.C., and director of the Imaging Program at Duke Cancer Center. "It was clear we needed a roadmap we could follow to avoid duplication and promote greater synergy."

Common Ground Located, New Paradigm Sought

At this year's roundtable, participants started on that process by breaking into three clinical groups—cardiology, oncology and osteoarthritis—as well as a group on funding, intellectual property (IP) and regulatory challenges. Charged with envisioning the role of biomarkers in 2025 while disregarding the current constraints of biology/pathology knowledge gaps and technology limitations, participants quickly found common ground on the need for everything from regulatory clarity to a national repository of biomarker data.

To begin plotting the future for imaging biomarkers, roundtable participants divided into various interest groups. Here, members of group on funding, intellectual property and regulatory challenges discuss the need to establish nationally recognized standards for biomarkers and to create a national repository of imaging biomarkers using those standards. Pictured are Morgan W. Nields (standing), William Ott, Ph.D. (seated, on left), and Walter Wolff, Ph.D.

The RSNA roundtable held in Chicago in March is the tip of the iceberg toward roadmapping the future for imaging biomarkers, said keynote speaker David M. Dilts, Ph.D., M.B.A. "We're doing this top-down as opposed to bottom-up," he said.

Participants also agreed that a whole new paradigm is needed for imaging biomarkers. "The shift needs to be made, with imaging biomarkers, from diagnosing end-stage disease to predicting and preventing disease," said Andrew J. Buckler, M.S., owner of Buckler Biomedical in Wenham, Mass., and facilitator of the oncology group. "Imaging may be the earliest tool in prevention and the least intrusive window into the preclinical phase of a disease."

Perhaps most pressing is the need to create standardized systems for the development, validation, qualification and use of accurate, repeatable and quantitative biomarkers across instruments and settings, said many roundtable participants.

Quantification will require developing hardware and/or software that significantly reduce quantitative image variances, resulting in imaging biomarker development that requires less money and time, as well as high quality clinical trials and better patient healthcare, roundtable members agreed.

As pointed out in the cardiovascular session, it will also require regulatory agencies to develop a clearer process for qualifying or validating biomarkers. "There should be an available suite of validated, qualified biomarkers, which should include getting regulatory agencies on the same page in terms of validation," said Mitchell D. Schnall, M.D., Ph.D., the Matthew J. Wilson Professor of Research Radiology and associate chair of research at the University of Pennsylvania Health System in Philadelphia.

National Biomarker Repository is Part of Vision

After using the breakout sessions to establish individual visions for the future, participants then met jointly to fuse core elements from each into one overarching vision for 2025. That plan includes creating:

• A valid and accurate collection of imaging biomarkers that are seamlessly integrated into clinical practice and clinical trials and are standard practice in prevention, screening and therapy, increasing the effectiveness, safety and quality of care. This will reduce overall cost and accelerate the transition of clinical research to the bedside.

• New imaging biomarkers supported by multiple partners—industry, government and foundations—and utilizing valid, widely used standards and endpoints as part of the majority of clinical trials.

• A national repository of well-characterized and quantified biomarker images maintained and linked with other biomarker repositories for use in evaluation of potential new imaging biomarkers.

• An infrastructure created to ensure the ongoing creation, optimization, validation and qualification of imaging biomarkers.

To that end, members of the funding/IP/regulatory breakout session, which included representatives from the U.S. Food and Drug Administration and the National Institutes of Standards and Technology, vowed to bring back to their management requests to establish nationally recognized standards for biomarkers within five years and to create a national repository of imaging biomarkers using those standards. "One of the most important things is regulatory clarity," said funding/IP/regulator facilitator Morgan W. Nields, president and CEO of INTIO in Broomfield, Colo.

In addition to the follow-up roundtable in June, other future steps include a meeting of RSNA's Quantitative Imaging Biomarkers Alliance (QIBA), planned for this month in Oak Brook, Ill. Formed in 2008, QIBA, chaired by Dr. Sullivan, is a group of stakeholders from pharmaceutical and medical device manufacturers, imaging informatics companies, government agencies, imaging societies and clinical trials groups committed to developing and adopting hardware and software standards to achieve accurate and reproducible quantitative results from imaging methods. QIBA's technical committees overseeing imaging biomarkers in three areas—fluorodeoxyglucose PET/CT, dynamic contrast-enhanced MR imaging and volumetric CT—will update their progress and strategize the next steps, said Dr. Sullivan.

Also growing out of these quantitative imaging activities will be an educational exhibit area at RSNA 2009 called the "Radiology Reading Room of the Future," in which industry vendors and academic research groups can demonstrate workstation tools for extracting quantitative results from imaging scans.