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Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

NCT05486572 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4700

Last updated 2026-04-21

No results posted yet for this study

Summary

The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.

Conditions

  • Carcinoma, Hepatocellular
  • Cirrhosis

Interventions

OTHER

Abbreviated Magnetic Resonance Imaging with serum AFP

Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8

OTHER

Abdominal Ultrasound Screening with serum AFP

abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • George N. Ioannou, MD MS · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2030-09-01
Completion
2031-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486572 on ClinicalTrials.gov