Five-Year Multicenter Metastatic Colorectal Cancer Trial Across 40 Sites

Challenge

A five-year multicenter clinical trial of a treatment for metastatic colorectal cancer enrolled hundreds of patients at more than 40 investigator sites. The length of the trial and the volume of imaging created operational risk: sites changing scanners and staff, image transfer delays accumulating over years, and the potential for reader drift across a long program.

The sponsor needed a core lab to manage acquisition, transfer and processing for the full duration and to provide oncology-subspecialized radiologists for consistent image interpretation from first patient to database lock.

Intrinsic Imaging’s Solution

Intrinsic Imaging established acquisition guidelines for contrast-enhanced CT and MRI, qualified the 40-plus sites and set up centralized transfer with receipt confirmation and quality control, including requalification when sites changed scanners during the five-year program.

Oncology-subspecialized radiologists performed blinded reads under a RECIST charter defining target lesion selection, liver lesion measurement conventions and progression confirmation, with adjudication of discordant assessments and periodic calibration sessions to maintain consistency across the program.

Project management tracked the imaging schedule for hundreds of patients over five years, monitoring per-site compliance and reader agreement at planned intervals.

Intrinsic Imaging’s Results

• Imaging from hundreds of patients at more than 40 sites acquired, transferred and processed centrally over five years
• Approximately 4,100 timepoints read under a single RECIST charter with adjudication and documented calibration
• Site requalification completed after 14 scanner changes with no loss of longitudinal comparability
• Reader agreement on response category maintained above 88% at each annual monitoring interval