Liver Cancer Disparities in American Indian and Alaska Native Persons Screening Trial Comparing Ultrasound and Abbreviated MRI with AFP Testing

What this Trial Is About

Researchers are conducting a pilot and feasibility randomized controlled trial to compare two methods of screening for hepatocellular carcinoma (HCC) among American Indian and Alaska Native (AI/AN) patients with cirrhosis or chronic hepatitis B virus infection. This study aims to evaluate the compliance and feasibility of screening protocols using abdominal ultrasound plus serum alpha-fetoprotein (AFP) testing versus abbreviated magnetic resonance imaging (aMRI) plus AFP testing every six months for one year. The trial will also assess the proportion of tests using appropriate protocols with LI-RADS documentation and the rate and stage of HCC diagnosis. Participants are randomly assigned to one of two groups: one receiving abdominal ultrasound and AFP testing at baseline, 6 months, and 12 months; the other receiving abbreviated MRI of the abdomen plus AFP testing at the same intervals. The study duration is 12 months, with screening conducted three times. Both screening methods are diagnostic tests evaluated under this trial. During the study, participants will undergo screening tests at three timepoints to monitor liver cancer risk and screen for HCC. Researchers will assess adherence to the screening schedule and the quality of test documentation. The primary outcomes include compliance with and feasibility of the screening protocols over 12 months. Safety and participant ability to complete visits will be monitored throughout, ensuring comprehensive data collection and follow-up within the study period.

Liver Cancer Disparities in American Indian and Alaska Native Persons