Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Kathryn Fowler, MD

Description

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.

Official Title

Abbreviated MRI (AMRI) vs. Ultrasound for HCC Surveillance in Cirrhosis

Details

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.

Keywords

Liver Cancer Liver Cirrhoses Liver Carcinoma Carcinoma Carcinoma, Hepatocellular Liver Cirrhosis Fibrosis Diethylenetriamine Edetic Acid Pentetic Acid Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Kathryn Fowler, MD
    Professor Of Clinical, Radiology. Authored (or co-authored) 23 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04288323
Phase
Phase 4
Study Type
Interventional
Last Updated