Status:
RECRUITING
Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) Vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients with Cirrhosis
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Icahn School of Medicine at Mount Sinai
Conditions:
Liver Cancer
Liver Cirrhoses
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Ultrasound (US) is currently used for HCC surveillance. However, US has certain limitations, so physicians use contrast CT or MRI. However, these are expensive and time-consuming procedures. We introd...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04288323
Start Date
April 27 2018
End Date
December 30 2025
Last Update
November 25 2024
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92037