RecruitingCarcinoma, HepatocellularCirrhosis

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

Eligible age

18–75 yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this 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.

Sponsor: VA Office of Research and Development

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.