Hepatocellular Carcinoma Trial Using mRECIST

Challenge

Assessment of hepatocellular carcinoma under mRECIST hinges on measuring viable, enhancing tumor rather than overall lesion size—making the timing of the arterial phase absolutely critical. Across 50 sites in 12 countries, variation in multiphase acquisition timing had compromised the reliability of viable tumor measurements, since a poorly timed arterial phase can render enhancement unassessable. The trial's response-based endpoints required that every examination capture the contrast phases necessary for valid mRECIST assessment.

Our Solution

Intrinsic Imaging standardized multiphase acquisition protocols across all participating sites, with phase timing verified on every submission at the point of receipt. Non-conformant studies were flagged immediately, allowing sites to correct acquisition technique before further patients were affected. Only then did examinations proceed to central review by abdominal radiologists, who applied mRECIST and LI-RADS criteria to imaging of consistent, verified quality.

Results

• Evaluable scan rate above 97%
• Reliable viable tumor measurements
• Central review supported the regulatory filing