BICR Approaches in Hepatocellular Cancer Clinical Trials with Emerging Therapies

Imaging is essential in hepatocellular carcinoma (HCC) clinical trials, guiding diagnosis and monitoring treatment efficacy. Among the most valuable tools are triphasic CT and/or MRI, which significantly improve diagnostic accuracy by differentiating liver tumors from surrounding tissues and assessing treatment efficacy, making them indispensable for clinical trials involving both traditional and emerging therapies.

HCC is the most common form of primary liver cancer and a leading cause of cancer-related deaths globally. Early detection and personalized treatment are critical for improving outcomes. Triphasic scans, which capture liver perfusion in arterial, venous, and delayed phases, provide detailed assessments of tumor vascularity and tissue characterization. These scans are essential for accurate staging and monitoring in HCC trials, particularly in distinguishing malignant from benign lesions and detecting subtle changes in arterial enhancement or necrosis.

Understanding the HCC tumor microenvironment is key to developing targeted therapies, as these tumors exhibit significant heterogeneity at the cellular level. The modified RECIST (mRECIST) criteria was introduced to address limitations of RECIST 1.1, specifically for HCC. While RECIST 1.1 primarily evaluates changes in tumor size, mRECIST incorporates the assessment of viable (enhancing) tumor tissue, focusing on the unique vascular characteristics of HCC. This is particularly important for therapies that induce necrosis without significant tumor shrinkage. Consistent imaging methods, appropriate endpoint selection, and standardized criteria like RECIST 1.1 and mRECIST with additional clarifications and modifications for trial optimization, are essential for ensuring reliable assessments in blinded independent central review (BICR) for clinical trials.

The use of mRECIST offers a more accurate evaluation of HCC treatment response which is particularly valuable given HCC’s complexity. Advanced imaging techniques such as dynamic contrast-enhanced MRI and PET-CT further provide insights into tumor characteristics beyond size, including vascularity and metabolic activity. These techniques are crucial across all trial phases, from early exploratory studies to late-phase registration trials, ensuring robust data that supports drug development at every stage.

Imaging Endpoints is a global leader in designing imaging protocols for HCC clinical trials, with a flawless inspection record and a 95% marketing authorization success rate across all supported trials. To connect with our experienced medical and scientific team, who specialize in optimizing imaging charters incorporating RECIST and mRECIST. Discover how our tailored imaging solutions can support your HCC clinical trials.