RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2018-04-27
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04288323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
  2. * Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology,
  3. * 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.
  1. * VA patient
  2. * \< 18 years of age
  3. * History of any liver cancer
  4. * MRI contraindication(s)
  5. * Subject knows that she is pregnant or states she trying to become pregnant
  6. * Positive urine pregnancy test in woman of childbearing potential
  7. * Nursing mother
  8. * Subject has known allergy to any gadolinium agent
  9. * Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist\*
  10. * Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent

Contacts and Locations

Study Contact

Alexandra Schlein
CONTACT
(858) 246- 2199
a1schlein@health.ucsd.edu
Yesenia Covarrubias
CONTACT
(858) 246 - 2198
ycovarrubias@health.ucsd.edu

Principal Investigator

Claude B Sirlin, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Claude B Sirlin, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-27
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2018-04-27
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Cancer
  • Liver Cirrhoses
  • Liver Carcinoma