The University of Michigan Rogel Cancer Center has created a solution to modernize, digitize and scale up the analyses of patient response during cancer trials: a tumor response assessment core or “TRAC,” an innovative approach to analyzing the medical scans of patients in clinical trials to improve accuracy of trial results while reducing the workload for busy oncologists. This new approach will become instrumental moving forward in running a major cancer research center.
The results of a recent study are based on an approach first implemented at University of Michigan (U-M) in 2016. It is believed that this new approach could serve as a model for improving imaging assessments at other cancer centers involved with clinical trials.
As the number of cancer-focused clinical trials grow across the country, the effectiveness of new drugs on treatment approach is often evaluated based on measurements of changes seen in patients’ tumors using a variety of imaging techniques—from MRI and CT to PET scans.
Individual variability and unintentional bias on the part of the physicians (investigators) interpreting these scans can skew the results. Unfortunately, this can impact the study results—making new therapies seem either better or worse than they actually are. Moreover, patient care can be affected—leading to patients either being taken off or staying in trials when they shouldn’t.
Time to Scale Cancer Trial Image Analysis
Medical oncologists aren’t trained to the same level and extent in quantitative imaging and analysis as their colleagues in radiology and nuclear medicine. Moreover, it is quite difficult for them to be deeply versed in the many evaluation methods employed across different clinical trials on top of their already very busy caseload of patients. Moreover, medical oncologists form unintentional bias based on their familiarity with patients.
The Solution: TRAC
U-M’s Rogel Cancer Center launched TRAC in 2016 to overcome the challenges mentioned above. The mission of this new system called TRAC was to create an independent, unbiased and verifiable system to measure patient response during clinical trials. U-M has to modify the division of labor to capitalize on this new approach. They created a new image analyst role, staffed with highly trained specialists. A new workflow was created that included an initial review by the image analyst, followed by review by radiologists who specialize in that particular type of cancer. The process also included a method for involving outside input to help resolve disagreements or ambiguities
Hence, U-M embarked on the TRAC study, which was published in JCCN, the Journal of the National Comprehensive Cancer Network—which revealed that, in fact, using this approach can lead to better measurements. According to the recent U-M originated press release, only a handful of cancer centers nationwide have developed a similar system—inclusive of dedicated imaging cores and web-based platforms. Prior to the TRAC approach, most imaging analyses were accomplished by individual medical oncologists in an approach that given the volume of trials and vast amounts of data, becomes less sustainable by the year.
The TRAC Study
TRAC has been used in more than 175 clinical trials across many types of cancer, assisting with assessments of more than 1,500 scans. In the recent study to analyze TRAC’s effectiveness, researchers used records for 49 lung cancer patients treated at U-M between 2005 and 2015, before the new system was in place.
The patients’ imaging scans were sent through the TRAC process, where they were reviewed by an image analyst and two board-certified radiologists; another radiologist also performed a separate, independent review. These results were then compared to the medical oncologists’ original assessments.
Incredible Efficiency Gains
The team found additional benefits from the implementation of TRAC—efficiency gains. U-M found that the turnaround time for tumor measurements decreased from 33 days to 3 days.
Observations by Study Lead
Vaibhav Sahai, MBBS, a medical oncologist at Michigan Medicine and senior author of the study, noted, “We found substantial agreement between the TRAC analysis and the radiologists’ evaluation.” Moreover, Sahai commented, “We found only moderate agreement between the assessments by medical oncologists and TRAC. These differences have the potential to affect patient treatment and outcomes.” He continued, “At any given moment, we have hundreds of people enrolled in clinical trials at our cancer center. Before TRAC, the majority of the imaging analyses were done by medical oncologists, and this is very common across the country.”
About the University of Michigan Rogel Cancer Center
The Rogel Cancer Center was founded in 1986 at the University of Michigan. In 1988, it was designated as part of the National Cancer Institute cancer centers program. It received comprehensive cancer center status in 1991 and continues to be an NCI-designated comprehensive cancer center today. From 1991-2018, it was known as the University of Michigan Comprehensive Cancer Center. It was renamed the Rogel Cancer Center in 2018 in recognition of a $150 million commitment from Richard and Susan Rogel. It is ranked among the top cancer programs by U.S. News & World Report. The Rogel Cancer Center is a founding member of the National Comprehensive Cancer Network.
Vaibhav Sahai, MBBS, a medical oncologist at Michigan Medicine and senior author of the study