Liver Cancer Disparities in American Indian and Alaska Native Persons

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Liver Cancer Disparities in American Indian and Alaska Native Persons

Conditions
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Hepatocellular Carcinoma, Cirrhosis, Liver, Hepatitis B

Intervention / Treatment
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* Diagnostic Test: Ultrasound or abbreviated MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound + AFP<br>Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months | Diagnostic Test: Ultrasound or abbreviated MRI<br>* Abdominal ultrasound or abbreviated MRI<br>|
| Active Comparator: aMRI + AFP<br>Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months | Diagnostic Test: Ultrasound or abbreviated MRI<br>* Abdominal ultrasound or abbreviated MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with screening protocol | Compliance with conducting all three screening tests | 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 | 12 months |