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

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    University of California, San Diego
Updated on 19 February 2024
carcinoma
cirrhosis
hepatocellular carcinoma

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.

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 introduced an abbreviated MRI (AMRI) exam, which works well in cirrhotic and obese patients (unlike US), involves no ionizing radiation (unlike CT), and is rapid (unlike multi-phasic MRI) with total scanner times of less than ten minutes, and can be performed at about the same cost as US. This study in adult patients with cirrhosis will compare the performance of AMRI vs. US for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for HCC screening in high-risk individuals.

Details
Condition Cirrhosis, LIVER DISEASE, LIVER DISEASE, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA
Age 18years - 100years
Treatment Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Clinical Study IdentifierNCT04288323
SponsorUniversity of California, San Diego
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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