Hepatocellular Carcinoma Screening in American Indian and Alaska Native Patients with Cirrhosis or Hepatitis B Virus

Status: active

This phase II trial compares how well abdominal abbreviated magnetic resonance imaging (aMRI) works in comparison to standard of care ultrasound for screening for hepatocellular carcinoma in American Indian/ Alaska Native patients with cirrhosis or hepatitis B virus (HBV). aMRI is a tailored version of magnetic resonance imaging (MRI) that aims to decrease the time it takes to take and interpret images while maintaining high sensitivity and is currently one of the gold-standard diagnostic tests for hepatocellular carcinoma. Ultrasound imaging uses high-frequency sound waves to generate images of the body. Undergoing aMRI may work better at detecting hepatocellular carcinoma in American Indian/ Alaska Native patients with cirrhosis or HBV.

Inclusion Criteria

Patients with chronic HBV or cirrhosis (standard histologic, radiologic or clinical criteria) of any etiology with a high HCC risk
Patients with cured hepatitis C virus (HCV), who developed cirrhosis prior to HCV eradication, will be included in the study, since we showed that they continue to have substantial HCC risk for many years after HCV eradication
Age >=18 (no upper age limit)

Exclusion Criteria

Prior HCC
Child’s C Cirrhosis (Child-Turcotte-Pugh [CTP] score >= 10)
Model for End-Stage Liver Disease (MELD) score > 20
Listed for liver transplantation
Contra-indications to MRI
Comorbidities with life expectancy < 5 years
Patients with glomerular filtration rate (GFR) < 30 ml/min will be excluded to mitigate theoretical risks of gadolinium-based contrast agents

PRIMARY OBJECTIVE:

I. Perform a pilot and feasibility randomized controlled trial of abbreviated MRI (aMRI) versus ultrasonography (US) for hepatocellular carcinoma (HCC) screening in 200 American Indian/ Alaska Native (AI/AN) patients who have high HCC risk.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive gadolinium intravenously (IV) and undergo abdominal aMRI at baseline, 6 months, and 12 months on study. Patients also undergo blood collection throughout the study.

ARM II: Patients undergo standard of care abdominal US at baseline, 6 months, and 12 months on study. Patients also undergo blood collection throughout the study.

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Hepatocellular Carcinoma Screening in American Indian and Alaska Native Patients with Cirrhosis or Hepatitis B Virus

Inclusion Criteria

Exclusion Criteria

United States

Oklahoma

Talequah

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Hepatocellular Carcinoma Screening in American Indian and Alaska Native Patients with Cirrhosis or Hepatitis B Virus

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