Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Recruiting now · Not applicable

Conditions studied: Carcinoma, Hepatocellular, Cirrhosis

In brief

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.

Key facts

Study ID

NCT05486572

Run by

VA Office of Research and Development

People needed

4700

Starts

2023-11-03

Expected to finish

2031-09-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Age 18-75
• Able to provide informed consent

You may not qualify if…

• 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 it is running

• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States (enrolling)
• Southern Arizona VA Health Care System, Tucson, AZ — Tucson, Arizona, United States (enrolling)
• Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock, Arkansas, United States (enrolling)
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
• VA Northern California Health Care System, Mather, CA — Sacramento, California, United States (enrolling)
• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (enrolling)
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (enrolling)
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (enrolling)
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (enrolling)
• Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States (enrolling)
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States (enrolling)
• Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (enrolling)
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (enrolling)
• Robley Rex VA Medical Center, Louisville, KY — Louisville, Kentucky, United States (enrolling)
• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (enrolling)
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (enrolling)
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (enrolling)
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States (enrolling)
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (enrolling)
• VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (enrolling)
• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States (enrolling)
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (enrolling)
• Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC — Salisbury, North Carolina, United States (enrolling)
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.