FAST (Focused Abbreviated Screening Technique)-MRI Study

Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (~30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation.

This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.

Inclusion criteria

• Liver cirrhosis of any etiology.
• 18 years of age and older.
• Enrolled in screening/surveillance program for HCC.
• Clinically indicated imaging-based screening for HCC.
• Willing and able to complete all study procedures within specified time windows.
• Patient is able to give informed consent for this study.

Exclusion criteria

• Contra-indications to MRI.
• Age less than 18 years.
• Patients with chronic renal failure or inability to tolerate contrast.
• Inability to undergo MRI due to lack of insurance coverage.
• Prior negative screening exam less than 5 months prior to enrollment.
• Prior hepatic resection.
• Post liver transplantation.
• Previously treated HCC or other liver neoplasm.
• Any other condition or factor that in judgment of study investigator may interfere with study completion.