Liver Cancer Disparities in American Indian and Alaska Native Persons

University of Washington

Status and phase: Enrolling; Phase 2

Conditions: Cirrhosis, Liver; Hepatocellular Carcinoma; Hepatitis B

Treatments: Diagnostic Test: Ultrasound or abbreviated MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05304234

STUDY00013583

1P20CA252732-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ultrasound + AFP

Active Comparator group

Description:

Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months

Treatment:

Diagnostic Test: Ultrasound or abbreviated MRI

aMRI + AFP

Active Comparator group

Description:

Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months

Treatment:

Diagnostic Test: Ultrasound or abbreviated MRI