Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma; Icahn School of Medicine at Mount Sinai
• Treatments: Diethylenetriamine; Edetic Acid; Pentetic Acid

Criteria

Inclusion Criteria:

• Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.

• Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology,

• Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.

Exclusion Criteria:

• VA patient

• < 18 years of age

• History of any liver cancer

• MRI contraindication(s)

• Subject knows that she is pregnant or states she trying to become pregnant

• Positive urine pregnancy test in woman of childbearing potential

• Nursing mother

• Subject has known allergy to any gadolinium agent

• Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist*

• Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent