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RECRUITING
NCT05486572
NA

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

4700

Start Date

2023-11-03

Completion Date

2031-09-01

Last Updated

2025-09-26

Healthy Volunteers

No

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

Locations (17)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, United States

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States