Liver Cancer Disparities in American Indian and Alaska Native Persons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hepatocellular Carcinoma Cirrhosis, Liver Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Ultrasound + AFP

Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months

Group Type ACTIVE_COMPARATOR

Ultrasound or abbreviated MRI

Intervention Type DIAGNOSTIC_TEST

Abdominal ultrasound or abbreviated MRI

aMRI + AFP

Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months

Group Type ACTIVE_COMPARATOR

Ultrasound or abbreviated MRI

Intervention Type DIAGNOSTIC_TEST

Abdominal ultrasound or abbreviated MRI

Interventions

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Ultrasound or abbreviated MRI

Abdominal ultrasound or abbreviated MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No