Liver Cancer Disparities in American Indian and Alaska Native Persons
Recruiting · NCT05304234 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
Ultrasound or abbreviated MRI
What this trial is 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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Cherokee Nation Health Service - Tahlequah, Oklahoma, United States