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Comparing Ultrasound vs. MRI for Liver Cancer Screening

This study, called PREMIUM, is looking for people aged 18-75 with cirrhosis (scarring of the liver) to compare two ways of screening for liver cancer. You would be randomly assigned to receive either an abdominal ultrasound (US) or an abbreviated MRI (aMRI), both combined with a blood test called AFP, every six months for eight years. The goal is to see if one screening method can detect liver cancer earlier, leading to more effective treatments and ultimately reducing deaths from liver cancer. The study is currently recruiting 4700 participants across 47 VA Medical Centers.

Study design
This is a randomized study comparing two screening methods, with 2350 participants in each group, for a total of 4700 participants.
What's involved
You would receive either an abdominal ultrasound or an abbreviated MRI, plus a blood test (AFP), every six months for eight years.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, liver cancer mortality, will be measured at 8 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05486572

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Recruiting
NAAges 18–75InterventionalPrevention
VA Office of Research and Development
~4,700 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Abbreviated Magnetic Resonance Imaging with serum AFPAbdominal Ultrasound Screening with serum AFP

At a glance

Recruiting sites
33 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hepatocellular Carcinoma Mortality
Measured over 8 years

Conditions

Carcinoma, Hepatocellular
Cirrhosis

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Where it's being run

34 sites across 25 states
California5
Florida2
New York2
North Carolina2
South Carolina2
Texas2
Alabama1
Arizona1

Study leadership

  • George N. Ioannou, MD MS · STUDY_CHAIR · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Who to contact

George N Ioannou, MD MS
[email protected]
(206) 277-3136
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Hepatocellular Carcinoma Mortality8 years

    death due to liver cancer