This study compares the diagnostic value of an abbreviated magnetic resonance imaging (MRI) protocol compared to ultrasound (or sonography) for screening of liver cancer. MRI uses magnetic waves to look at soft tissues in the body. Ultrasound uses high-frequency sound waves to produce precise images of soft tissues within the body. Information gained from this trial may help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04539717.
PRIMARY OBJECTIVES:
I. To determine the diagnostic performance of abbreviated magnetic resonance imaging obtained during the hepatobiliary phase (HBP-AMRI) post gadoxetic acid versus (vs.) ultrasound (US) for hepatocellular carcinoma (HCC) screening in Americans with cirrhosis.
II. To determine the added value of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and serum alpha-fetoprotein (AFP) for improving HCC detection by HBP-AMRI or US in Americans with cirrhosis.
III. To assess the cost-effectiveness of HBP-AMRI vs. US for HCC screening in Americans with cirrhosis.
EXPLORATORY OBJECTIVE:
I. To assess the diagnostic performance of dynamic abbreviated MRI (Dyn-AMRI) vs HBP-AMRI vs US for HCC screening in Americans with cirrhosis.
OUTLINE:
Patients undergo ultrasound of the liver over 30 minutes and MRI over 1.5 hours.
After completion of study intervention, patients are followed up for 6 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorBachir Taouli