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Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
Sponsor: VA Office of Research and Development
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
Conditions
Interventions
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
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