Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs

What this Trial Is About

Researchers are investigating the use of Fast-MRI combined with liver ultrasound versus liver ultrasound alone for early detection of hepatocellular carcinoma (HCC) in patients at high risk due to cirrhosis. This study focuses on patients with an anticipated annual HCC incidence greater than 3%, aiming to evaluate cost-effectiveness and detection rates of early-stage HCC, which is crucial for curative treatments. The trial is a randomized controlled, multicenter study comparing these two surveillance methods in a high-risk population with either non-viral or controlled viral cirrhosis. Participants are randomized into two groups: one receiving semi-annual liver ultrasound plus Fast-MRI, and the other receiving semi-annual liver ultrasound alone. Fast-MRI uses short imaging protocols lasting less than 10 minutes, focusing on sequences with high detection sensitivity. At each six-month visit, if either imaging detects a nodule, further characterization is performed through additional imaging or biopsy following international guidelines, with diagnosis confirmed by multidisciplinary consultation. During the study, participants undergo regular imaging tests every six months for up to three years. Researchers will measure the cost per quality-adjusted life year (QALY), detection rates of very early-stage HCC, sensitivity, specificity, rates of curative treatments, survival, and compliance. Quality of life will be assessed using the EQ-5D5L scale. The study includes economic evaluations from the healthcare system perspective and considers long-term costs and benefits updated annually. Participants will be closely monitored to track outcomes and safety throughout the study period.

FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.