Global Hepatocellular Carcinoma Trial With Dynamic Contrast-Enhanced MRI

Challenge

A global clinical trial of a new therapy for hepatocellular carcinoma used dynamic contrast-enhanced MRI to assess tumor response, with heavy enrollment in Asia where HCC incidence is highest. DCE-MRI requires precise contrast timing and multiphase acquisition, and the arterial-phase enhancement on which modified RECIST depends is easily lost with mistimed acquisition or respiratory motion in patients with cirrhosis and ascites.

The sponsor needed multiphase acquisition standardized across continents and vendor platforms, response assessed under mRECIST with reproducible identification of viable enhancing tumor, and quantitative perfusion parameters extracted consistently where the protocol required them.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the protocol imaging section and charter with a DCE-MRI protocol specifying bolus timing, phase acquisition and sequence parameters for each vendor platform, and qualified every site with test acquisitions reviewed for arterial-phase timing. Site training addressed breath-hold coaching in patients with limited respiratory reserve.

Oncology and abdominal radiologists performed blinded independent reads under mRECIST, with the charter defining viable tumor measurement, handling of treated lesions and new lesion criteria in the cirrhotic liver. Quantitative perfusion parameters were extracted under fixed region-of-interest conventions, and discordant response categories were adjudicated.

Image transfer, blinding and processing were centralized across regions, with arterial-phase timing verified at receipt and deviations returned to sites with specific corrective guidance.

Intrinsic Imaging’s Results

• DCE-MRI standardized across 44 sites in 11 countries with vendor-specific protocols and arterial-phase qualification
• Approximately 1,900 timepoints assessed under blinded mRECIST double reads with adjudication
• Arterial-phase timing compliance improved from 81% at qualification to above 95% during enrollment through targeted site feedback
• Quantitative perfusion parameters delivered under fixed conventions alongside mRECIST response for the sponsor's analysis