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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Ultrasound + AFP |
Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months |
|
|
Active Comparator aMRI + AFP |
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months |
|
Recruiting Locations
Tahlequah, Oklahoma 74464
Jorge Mera
More Details
- Status
- Recruiting
- Sponsor
- University of Washington
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