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Comparing Ultrasound and MRI for Early Detection of Liver Cancer

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

Not applicable Interventional VA Office of Research and Development · NCT05486572

This study is testing whether a special type of MRI can find liver cancer earlier than the usual ultrasound in patients with cirrhosis.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment4700 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorVA Office of Research and Development Federal
Drugs / interventionschemotherapy
Locations32 sites (Birmingham, Alabama and 31 other locations)
Trial IDNCT05486572 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized controlled trial aimed at comparing two screening methods for early detection of hepatocellular carcinoma (HCC) in patients with cirrhosis. Participants will be assigned to receive either abdominal ultrasound with serum alpha fetoprotein (AFP) or abbreviated magnetic resonance imaging (aMRI) with AFP, both conducted every six months. The study seeks to determine if aMRI can detect HCC at earlier stages compared to the standard ultrasound method, potentially leading to more effective treatments and reduced mortality rates. The trial will involve approximately 4,700 patients across 47 VA Medical Centers over three years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with cirrhosis and an estimated annual risk of developing HCC greater than 2.5%.

Not a fit: Patients with prior liver cancer, severe cirrhosis, or contraindications to MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of liver cancer, improving treatment outcomes and reducing mortality for patients with cirrhosis.

How similar studies have performed: Other studies have shown promising results with similar imaging approaches for early cancer detection, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, HepatocellularCirrhosishepatic, oncologyliverchronic diseaseshealth services and systemsprospective, randomized, clinical trialmagnetic resonance imaging
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.