Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05486572

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Led by VA Office of Research and Development · Updated on 2026-04-21

4700

Participants Needed

32

Research Sites

408 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cirrhosis diagnosed by liver biopsy, imaging, clinical signs, or elastography
  • High risk of liver cancer defined by current hepatitis C infection, FIB-4 score ≥3.25, or estimated annual HCC risk >2.5%
  • Age between 18 and 75 years
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Prior or suspected diagnosis of hepatocellular carcinoma (HCC)
  • Previous organ transplant or currently listed for transplant
  • Participation in another liver cancer screening trial
  • Advanced liver disease defined by Child C Cirrhosis or MELD score >20
  • Severe kidney dysfunction with GFR <30 ml/min
  • Multiple serious health conditions limiting life expectancy
  • Estimated life expectancy less than 5 years
  • Contraindications to contrast-enhanced MRI, including allergies, incompatible implants, or severe claustrophobia
  • Unable to complete study visits due to travel or transportation issues
  • Currently pregnant

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 32 locations

1

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States, 35233-1927

Actively Recruiting

2

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, United States, 85723-0001

Actively Recruiting

3

Central Arkansas Veterans Healthcare System , Little Rock, AR

Little Rock, Arkansas, United States, 72205

Actively Recruiting

4

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States, 90822

Actively Recruiting

5

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States, 94304-1207

Actively Recruiting

6

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States, 95655-4200

Actively Recruiting

7

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Actively Recruiting

8

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

West Los Angeles, California, United States, 90073-1003

Actively Recruiting

9

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States, 80045-7211

Actively Recruiting

10

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

West Haven, Connecticut, United States, 06516-2770

Actively Recruiting

11

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, United States, 20422-0001

Actively Recruiting

12

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States, 33125

Actively Recruiting

13

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States, 33612

Active, Not Recruiting

14

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States, 30033-4004

Actively Recruiting

15

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

Baltimore, Maryland, United States, 21201

Actively Recruiting

16

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

Boston, Massachusetts, United States, 02130-4817

Actively Recruiting

17

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States, 48105-2303

Actively Recruiting

18

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

St Louis, Missouri, United States, 63106-1621

Actively Recruiting

19

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

Omaha, Nebraska, United States, 68105-1850

Actively Recruiting

20

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States, 10010-5011

Actively Recruiting

21

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States, 10468-3904

Actively Recruiting

22

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Actively Recruiting

23

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States, 44106-1702

Actively Recruiting

24

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97207-2964

Actively Recruiting

25

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

Philadelphia, Pennsylvania, United States, 19104-4551

Actively Recruiting

26

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States, 29401-5703

Actively Recruiting

27

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

Columbia, South Carolina, United States, 29209-1638

Actively Recruiting

28

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

Dallas, Texas, United States, 75216-7167

Actively Recruiting

29

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States, 77030-4211

Actively Recruiting

30

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

Salt Lake City, Utah, United States, 84148-0001

Actively Recruiting

31

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

Seattle, Washington, United States, 98108-1532

Actively Recruiting

32

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States, 53705-2254

Actively Recruiting

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Research Team

G

George N Ioannou, MD MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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