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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
200
Abdominal ultrasound or abbreviated MRI
Cherokee Nation Health Service
Tahlequah, Oklahoma, United States
RECRUITINGCompliance with screening protocol
Compliance with conducting all three screening tests
Time frame: 12 months
Feasibility of screening protocol
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system
Time frame: 12 months
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