NCT05486572 · VA Office of Research and Development
Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
(PREMIUM)
What this study is about
The study is a randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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).
- Able to provide informed consent
Exclusion criteria
- Prior diagnosis or of HCC
- Current suspicion of HCC
- Prior receipt of organ transplantation
- Currently listed for organ transplantation.
- Participation in a conflicting HCC screening trial
- Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \>20, within 6 months prior to randomization
- Glomerular Filtration Rate (GFR) \<30 ml/min
- 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.
- Estimated life expectancy \<5 years as determined by the clinical judgement of the Study Investigator
- 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
- Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)
- Currently pregnant
Where
- Birmingham, Alabama
- Tucson, Arizona
- Little Rock, Arkansas
- Long Beach, California
- Palo Alto, California
- Sacramento, California
- San Diego, California
- West Los Angeles, California
- Aurora, Colorado
- West Haven, Connecticut
- Washington D.C., District of Columbia
- Miami, Florida
And 22 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations