Liver Cancer Disparities in American Indian and Alaska Native Persons

Purpose

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.

Conditions

  • Hepatocellular Carcinoma
  • Cirrhosis, Liver
  • Hepatitis B

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Ultrasound + AFP 		Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
  • Diagnostic Test: Ultrasound or abbreviated MRI
    Abdominal ultrasound or abbreviated MRI
Active Comparator
aMRI + AFP 		Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
  • Diagnostic Test: Ultrasound or abbreviated MRI
    Abdominal ultrasound or abbreviated MRI

Recruiting Locations

Cherokee Nation Health Service
Tahlequah, Oklahoma 74464
Contact:
Jorge Mera

More Details

Status
Recruiting
Sponsor
University of Washington

Study Contact

Jennifer R Harry
206-616-0397
jharry@medicine.washington.edu

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