Liver Cancer Disparities in American Indian and Alaska Native Persons

Liver Cancer Disparities in American Indian and Alaska Native Persons

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 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:

1. Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
2. Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
3. Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome

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