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RECRUITING

NCT05486572

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

2026-04-21

Healthy Volunteers

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

Inclusion Criteria: 1. Cirrhosis due to any underlying etiology diagnosed by one or more of the following: * Histology of liver biopsy * Radiologic criteria (nodular liver, evidence of portal hypertension) * Clinical signs of cirrhosis (gastroesophageal varices, ascites, hepatic encephalopathy) * Vibration controlled transient elastography (VCTE, specifically Fibroscan, which is available in all participating sites) with liver stiffness \>12.5kPa or magnetic resonance elastography \>5.0 kPa 2. High Risk of Liver Cancer: This will be defined by one or more of the following: * Current HCV infection (detectable HCV RNA) * FIB-4 score 3.25, within 6 months of randomization * Estimated annual HCC incidence \>2.5%, within 6 months of randomization, calculated by VA-specific models that the investigators developed (available on the national VA ALD Dashboard and at www.hccrisk.com). 3. Age 18-75 4. Able to provide informed consent Exclusion Criteria: 1. Prior diagnosis or of HCC 2. Current suspicion of HCC 3. Prior receipt of organ transplantation 4. Currently listed for organ transplantation. 5. Participation in a conflicting HCC screening trial 6. Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization 7. Glomerular Filtration Rate (GFR) \<30 ml/min 8. Multiple comorbid conditions resulting in limited life expectancy, defined by a cirrhosis-specific comorbidity index (CirCom)112 score 3. Of note, early stage malignancies of the bladder, lung, or prostate will not be excluded. 9. Estimated life expectancy \<5 years as determined by the clinical judgement of the Study Investigator 10. Contraindications to undergoing contrast-enhanced MRI: * Allergy to gadolinium-based contrast agents * MRI-incompatible implantable devices (e.g. pacemakers, defibrillators, resynchronization devices) * Implantable neurostimulation device * Implantable cochlear implant/ear implant * Drug infusion pumps (e.g. insulin pump, analgesic or chemotherapy pumps) * Metallic foreign bodies in or around the eye * Metallic fragments, such as bullets, shotgun pellets or shrapnel * Metallic body piercings that cannot be removed * Cerebral artery aneurysm clips * Severe claustrophobia * Unable to fit on MRI machine due to weight (weight \>400lbs) or body habitus 11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.) 12. Currently pregnant

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