Recruiting

Ultrasound vs. MRIPreventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Sponsor:

VA Office of Research and Development

Code:

NCT05486572

Conditions

Carcinoma, Hepatocellular

Cirrhosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Abbreviated Magnetic Resonance Imaging with serum AFP

Abdominal Ultrasound Screening with serum AFP

Study Details

Brief 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.

Conditions

Carcinoma, Hepatocellular

Cirrhosis

Study ID

NCT05486572

Start date

Nov 3, 2023

Status verified date

Jun, 2026

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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

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

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

Primary outcome measure

Hepatocellular Carcinoma Mortality [ Time Frame: 8 years ]

Central Contacts and Locations

Central contacts

George N Ioannou, MD MS

(206) 277-3136 George.Ioannou@va.gov

Locations

Birmingham VA Medical Center, Birmingham, AL

Recruiting

Birmingham, Alabama, United States, 35233-1927

Contacts

James Callaway, MD

205-933-8101 James.Callaway@va.gov

Southern Arizona VA Health Care System, Tucson, AZ

Recruiting

Tucson, Arizona, United States, 85723-0001

Contacts

Bhupesh Pokhrel, MD

520-792-1450 Bhupesh.Pokhrel@va.gov

Central Arkansas Veterans Healthcare System , Little Rock, AR

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Ragesh Thandassery, MD

Ragesh.Thandassery@va.gov

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Morgan R Timothy, MD

morgan.timothy@va.gov

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Cheung Ramsey, MD

650-493-5000 ramsey.cheung@va.gov

VA Northern California Health Care System, Mather, CA

Recruiting

Sacramento, California, United States, 95655-4200

Contacts

Anthony Albanese, MD

anthony.albanese@va.gov

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Heather Patton, MD

858-260-0190

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

Recruiting

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

Contacts

Joseph Pisegna, MD

joseph.pisegna@va.gov

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Ashley M Lane, MD

720-723-6773 ashley.lane6@va.gov

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

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Sofia Jakab, MD

sofia.jakab@va.gov

Washington DC VA Medical Center, Washington, DC

Recruiting

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

Contacts

Atoosa Rabiee, MD

202-745-8000 Atoosa.Rabiee@va.gov

Miami VA Healthcare System, Miami, FL

Recruiting

Miami, Florida, United States, 33125

Contacts

Binu John, MD

305-575-7000 Binu.John@va.gov

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Thuy-Van Hang, MD

404-321-6111 Thuy-Van.Hang@va.gov

Robley Rex VA Medical Center, Louisville, KY

Recruiting

Louisville, Kentucky, United States, 40206-1433

Contacts

Ashutosh Barve, MD

502-287-4000 ashutosh.barve@va.gov

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

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Zurabi Lominadze, MD

502-541-7093 Zurabi.Lominadze@va.gov

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

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Gyorgy Baffy, MD

gyorgy.baffy@va.gov

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Grace L Su, MD

grace.su@va.gov

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

Recruiting

St Louis, Missouri, United States, 63106-1621

Contacts

Melissa Kaltenbach, MD

314-652-4100

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

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Peter Mannon, MD

peter.mannon@va.gov

VA NY Harbor Healthcare System, New York, NY

Recruiting

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

Contacts

Daniel Dileo, MD

718-836-6600 Daniel.Dileo@va.gov

James J. Peters VA Medical Center, Bronx, NY

Recruiting

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

Contacts

Tae H Lee, MD

718-584-9000 tae.lee@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Cynthia Moylan, MD

919-286-0411 Cynthia.Moylan@va.gov

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Leon Kundrotas, MD

704-638-9000 leon.kundrotas@va.gov

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Percia Davitkav, MD

percia.davitkov@va.gov

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Janice Jou, MD

503-220-8262 Janice.Jou@va.gov

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4551

Contacts

David Kaplan, MD

david.kaplan@va.gov

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Don Rockey, MD

843-577-5011 Don.Rockey@va.gov

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

Recruiting

Columbia, South Carolina, United States, 29209-1638

Contacts

Nicholas Hoppmann, MD

Nicholas.Hoppmann2@va.gov

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

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Jacqueline Oleary, MD

214-857-0403 Jacqueline.Oleary@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Ruben Hernaez, MD

ruben.hernaez@va.gov

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

Recruiting

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

Contacts

Tuan Pham, MD

801-582-1565 Tuan.Pham@va.gov

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

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

George N Ioannou, MD MS

206-277-3136 George.Ioannou@va.gov

William S. Middleton Memorial Veterans Hospital, Madison, WI

Recruiting

Madison, Wisconsin, United States, 53705-2254

Contacts

Adnan Said, MD

adam.said@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

hepatic, oncology
liver
chronic diseases; health services and systems
prospective, randomized, clinical trial
magnetic resonance imaging; ultrasonography
cirrhosis; liver cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-17.