Recruiting
Phase 2

Observational Study

Sponsor:

University of Washington

Code:

NCT05304234

Conditions

Hepatocellular Carcinoma

Cirrhosis, Liver

Hepatitis B

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound or abbreviated MRI

Study Details

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.

Conditions

Hepatocellular Carcinoma

Cirrhosis, Liver

Hepatitis B

Study ID

NCT05304234

Start date

Apr 1, 2022

Status verified date

Jun, 2024

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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

Interventions

Ultrasound or abbreviated MRI

Abdominal ultrasound or abbreviated MRI

Primary outcome measure

  • Compliance with screening protocol [ Time Frame: 12 months ]
  • Feasibility of screening protocol [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jennifer R Harry

206-616-0397jharry@medicine.washington.edu

Stephanie Y Park

206-744-7050sypark22@uw.edu

Locations

Cherokee Nation Health Service

Recruiting

Tahlequah, Oklahoma, United States, 74464

More Information

Sponsor

University of Washington

Last update posted

Jun 4, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-06-04.