CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)
VA Office of Research and Development
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.
Description
Study Design. The investigators propose to conduct a randomized controlled trial of screening for hepatocellular carcinoma (HCC) by ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months (the current standard-of-care) versus abbreviated MRI (aMRI)+AFP every 6 months among patients with cirrhosis who have a high risk of HCC (estimated annual HCC risk \>2.5%). Study Population. Patients ages 18-75 with cirrhosis (standard histologic, radiologic, or clinical criteria) of any etiology, with estimated annual HCC risk \>2.5%. Exclusion Criteria: Prior HCC; Child C Cirrhosis (CTP score 10); ME…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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: *…
Interventions
- OtherAbbreviated Magnetic Resonance Imaging with serum AFP
Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8
- OtherAbdominal Ultrasound Screening with serum AFP
abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8
Locations (32)
- Birmingham VA Medical Center, Birmingham, ALBirmingham, Alabama
- Southern Arizona VA Health Care System, Tucson, AZTucson, Arizona
- Central Arkansas Veterans Healthcare System , Little Rock, ARLittle Rock, Arkansas
- VA Long Beach Healthcare System, Long Beach, CALong Beach, California
- VA Palo Alto Health Care System, Palo Alto, CAPalo Alto, California
- VA Northern California Health Care System, Mather, CASacramento, California