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Completed

NCT Number: NCT04288323

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid

Drug

This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....

Primary outcomes

  1. Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection

    Time frame: up to one year

    per-patient sensitivity, specificity, positive predictive (PPV), negative predictive value (NPV) and accuracy of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening

  2. Reader reliability of screening modalities

    Time frame: up to 12 months from completion of imaging

    the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2020
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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