Liver Cancer Disparities in American Indian and Alaska Native Persons

Phase 2

Recruiting

• Conditions: Hepatitis B; Hepatocellular Carcinoma; Cirrhosis, Liver
• Interventions: Diagnostic Test: Ultrasound or abbreviated MRI

• Registration Number: NCT05304234
• Lead Sponsor: University of Washington

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aMRI + AFP	Ultrasound or abbreviated MRI	Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Ultrasound + AFP	Ultrasound or abbreviated MRI	Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months

Primary Outcome Measures

Name	Time	Method
Compliance with screening protocol	12 months	Compliance with conducting all three screening tests
Feasibility of screening protocol	12 months	Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system

Trial Locations

Locations (1)

Cherokee Nation Health Service; 🇺🇸 Tahlequah, Oklahoma, United States