Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI
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
| Condition(s) | Carcinoma, Hepatocellular, Cirrhosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 inves |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | VA Office of Research and Development |
| Locations | Birmingham, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Long Beach, California, United States; Palo Alto, California, United States; Sacramento, California, United States (+26 more sites) |
| Start date | 2023-11-03 |
| NCT ID | NCT05486572 |
| Official listing | https://clinicaltrials.gov/study/NCT05486572 |