What this Trial Is About

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and a leading cause of cancer-related death worldwide, with a poor prognosis and common spread to other organs at advanced stages. In Denmark, HCC occurs at a rate of 5.2 per 100,000 people annually. Diagnosis in patients with liver cirrhosis is often made non-invasively using CT or MRI scans, though MRI may detect smaller lesions better. PET scans using the 18F-FDG tracer have limited sensitivity for HCC, so this study evaluates a new liver-specific tracer called 18F-FDGal, which has shown promise for detecting both liver and extrahepatic HCC. Patients suspected of or diagnosed with HCC will undergo an initial 18F-FDGal PET/CT or PET/MRI scan. Those receiving loco-regional treatments such as surgery, ablation, or embolization will have additional scans at 1-2 months and 3-5 months post-treatment. The PET images will be analyzed by specialists and compared with other imaging methods. The study plans to enroll about 25 patients yearly over five years, aiming for a total of 125 participants. Participants will be monitored through these imaging scans to assess the accuracy of 18F-FDGal in diagnosing and staging HCC, as well as its ability to evaluate liver metabolic function and treatment response. The main outcomes measured are the sensitivity and specificity of the PET tracer and liver metabolic function over five years. The study excludes patients who are pregnant, nursing, receiving systemic chemotherapy, or have severe kidney impairment, with total participation lasting throughout these imaging and follow-up procedures.

18F-FDGal PET/CT and PET/MRI in Patients With Hepatocellular Carcinoma