In 2015, the CQCI established a research service for providing standardized tumor measurements to support imaging response assessments required for primary and secondary endpoints of radiographic progression/response in interventional therapeutic clinical trials at Hunstman Cancer Institute (HCI) at the University of Utah. A collaborative agreement has been executed to utilize the Precision Imaging Metrics software and database developed by the Dana-Farber/Harvard Cancer Center Tumor Imaging Metrics Core. The CQCI team of image analysts, research radiologists, and imaging scientists utilize this software to perform objective measurements with automated calculations and logic checks based on the specific response criteria. These results can be viewed through a web-based interface by the PI and study team while complete audit trails are available for regulatory compliance of GCP and 21 CFR Part 11.
Since its inception, this service has supported approximately 100 completed clinical trials and is providing assessments for 200 active trials utilizing >20 different response criteria. The process begins with the review of all clinical trial protocols for imaging assessment requirements by CQCI staff, who participate in the HCI Feasability and Administrative Review (FAR) committee. The specific imaging response criteria for each trial are configured in a central web-based database that is accessed by study staff to order imaging assessments. Upon completion of imaging assessments, automated email is sent to investigators and study staff with a web link to review assessments. In addition to individual subject results, investigators can access automated real-time summary charts of trial progress (e.g., waterfall plots, spider plots, and pie charts of response rates).