🔎 Trials Near Me

Home › Liver Cancer (Hepatocellular Carcinoma) › NCT05486572

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Recruiting

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

Who can join

Ages 18 to 75 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: VA Office of Research and Development · Participants: 4,700 · Started: Nov 3, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05486572

Locations in the U.S.

AlabamaBirmingham VA Medical Center, Birmingham, AL, Birmingham
ArizonaSouthern Arizona VA Health Care System, Tucson, AZ, Tucson
ArkansasCentral Arkansas Veterans Healthcare System , Little Rock, AR, Little Rock
CaliforniaVA Long Beach Healthcare System, Long Beach, CA, Long Beach
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto
VA Northern California Health Care System, Mather, CA, Sacramento
VA San Diego Healthcare System, San Diego, CA, San Diego
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles
ColoradoRocky Mountain Regional VA Medical Center, Aurora, CO, Aurora
ConnecticutVA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven
District of ColumbiaWashington DC VA Medical Center, Washington, DC, Washington D.C.
FloridaMiami VA Healthcare System, Miami, FL, Miami
GeorgiaAtlanta VA Medical and Rehab Center, Decatur, GA, Decatur
KentuckyRobley Rex VA Medical Center, Louisville, KY, Louisville
MarylandBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore
MassachusettsVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston
MichiganVA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor
MissouriSt. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis
NebraskaOmaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha
New YorkVA NY Harbor Healthcare System, New York, NY, New York
James J. Peters VA Medical Center, Bronx, NY, The Bronx
North CarolinaDurham VA Medical Center, Durham, NC, Durham
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury
OhioLouis Stokes VA Medical Center, Cleveland, OH, Cleveland
OregonVA Portland Health Care System, Portland, OR, Portland
PennsylvaniaCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia
South CarolinaRalph H. Johnson VA Medical Center, Charleston, SC, Charleston
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC, Columbia
TexasVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas
Michael E. DeBakey VA Medical Center, Houston, TX, Houston
UtahVA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City
WashingtonVA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle
WisconsinWilliam S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.