RecruitingNot ApplicableNCT05486572

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

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


Sponsor

VA Office of Research and Development

Enrollment

4,700 participants

Start Date

Nov 3, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares ultrasound to MRI for liver cancer screening in people with cirrhosis, aiming to find the most effective method for early detection and reducing liver cancer deaths. **You may be eligible if...** - You are between 18 and 75 years old - You have cirrhosis (diagnosed by biopsy, imaging, or clinical signs) or are at high risk for liver cancer - You have current hepatitis C infection, a high FIB-4 score, or an estimated high annual risk of liver cancer - Your doctor considers you eligible for liver cancer surveillance **You may NOT be eligible if...** - You have already been diagnosed with liver cancer - You have received or are listed for an organ transplant - You have very advanced liver disease (Child-Pugh C, MELD score above 20) - Your kidney function is severely reduced (GFR below 30) - You have multiple serious illnesses that significantly limit life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAbbreviated Magnetic Resonance Imaging with serum AFP

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

OTHERAbdominal 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(32)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, United States

Central Arkansas Veterans Healthcare System , Little Rock, AR

Little Rock, Arkansas, United States

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

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, United States

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 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

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States

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

Omaha, Nebraska, United States

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

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

Philadelphia, Pennsylvania, United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 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

View Full Details on ClinicalTrials.gov

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NCT05486572


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