Overview
We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
Description
We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
We will compare the aMRI vs. the US arm with respect to the following outcomes:
- Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
- Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
- Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome
Eligibility
Inclusion Criteria:
- Cirrhosis, any etiology, or chronic HBV infection
- High risk of HCC
- Age 18-75
- Competent to provide informed consent
Exclusion Criteria:
- Prior diagnosis of HCC
- Current suspicion of HCC
- Prior receipt of any organ transplantation
- Participation in another HCC screening trial
- CTP score >=10
- MELD-Na score >20
- GFR<30
- Poor life expectancy (<5 years)
- Contraindication to MRI
- Inability to complete study visits
- Currently pregnant