This phase II trial compares how well abdominal abbreviated magnetic resonance imaging (aMRI) works in comparison to standard of care ultrasound for screening for hepatocellular carcinoma in American Indian/ Alaska Native patients with cirrhosis or hepatitis B virus (HBV). aMRI is a tailored version of magnetic resonance imaging (MRI) that aims to decrease the time it takes to take and interpret images while maintaining high sensitivity and is currently one of the gold-standard diagnostic tests for hepatocellular carcinoma. Ultrasound imaging uses high-frequency sound waves to generate images of the body. Undergoing aMRI may work better at detecting hepatocellular carcinoma in American Indian/ Alaska Native patients with cirrhosis or HBV.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05304234.
Locations matching your search criteria
United States
Oklahoma
Talequah
Cherokee Nation Health ServiceStatus: Active
Contact: Jorge Mera
Phone: 918-506-3973
PRIMARY OBJECTIVE:
I. Perform a pilot and feasibility randomized controlled trial of abbreviated MRI (aMRI) versus ultrasonography (US) for hepatocellular carcinoma (HCC) screening in 200 American Indian/ Alaska Native (AI/AN) patients who have high HCC risk.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive gadolinium intravenously (IV) and undergo abdominal aMRI at baseline, 6 months, and 12 months on study. Patients also undergo blood collection throughout the study.
ARM II: Patients undergo standard of care abdominal US at baseline, 6 months, and 12 months on study. Patients also undergo blood collection throughout the study.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorGeorge Ioannou
