Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Prior diagnosis or of HCC
Current suspicion of HCC
Prior receipt of organ transplantation
Currently listed for organ transplantation.
Trial design
Treatments tested in this trial
- Abbreviated Magnetic Resonance Imaging with serum AFP
- Abdominal Ultrasound Screening with serum AFP
Treatment groups
4,700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov