Cirrhosis, Liver, Hepatitis B, Hepatocellular Carcinoma
Conditions
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
Interventions
DIAGNOSTIC_TESTUltrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
Sponsors
National Cancer Institute (NCI)
Cherokee Nation Health Services
Alaska Native Tribal Health Consortium
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactJennifer R Harry
Backup ContactStephanie Y Park
Outcome results
None listed