RecruitingNot Applicable

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

United States4,700 participantsStarted 2023-11-03

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Cirrhosis due to any underlying etiology diagnosed by one or more of the following:
✓. High Risk of Liver Cancer: This will be defined by one or more of the following:
✓. Age 18-75
✓. 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.

What they're measuring

Hepatocellular Carcinoma Mortality

Timeframe: 8 years

Trial details

NCT IDNCT05486572

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2030-09-01

Contact for this trial

George N Ioannou, MD MS

(206) 277-3136 George.Ioannou@va.gov

View on ClinicalTrials.gov More Carcinoma, Hepatocellular trials