Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status: Unknown

Conditions: Hepatitis C; Cirrhosis; End Stage Liver Disease

Treatments: Procedure: Screening

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01350167

3034-A

Details and patient eligibility

About

The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.

Full description

Most cases of hepatocellular carcinoma (HCC) arise in patients with advanced liver disease, usually cirrhosis. Most patients with clinically evident HCC are not candidates for treatment with curative intent because of large tumor size, invasion of hepatic or portal veins, or metastatic disease. For this reason, screening for HCC at an asymptomatic and potentially curable stage in patients with advanced liver disease has been recommended by some authorities. Screening with various methods, of which ultrasound (US) and alpha-fetoprotein (AFP) have been the most extensively studied, has become accepted practice. Recently the technique of imaging the liver with or during both the hepatic arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown increased sensitivity in detecting HCCs compared to US.

The hypothesis of this study is that CT using a "liver-shuttle" protocol once a year is more sensitive and specific than US twice a year, both in combination with AFP for identification of potentially curable HCC in patients with cirrhosis. Patients will be randomized to "routine," accepted screening with hepatic US and AFP testing every 6 months or AFP testing every 6 months wtih triphasic CT every 12 months.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis
• potential candidate for treatment of HCC
• imaging study involving the liver in the last 12 months without evidence for HCC
• must be a veteran in VISN 23

Exclusion criteria

• active or untreated malignancy other than non-melanoma skin cancer
• patients with advanced medical conditions such as severe cardiovascular disease, COPD, or severe end-stage liver disease
• patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy
• history of liver mass identified on imaging study

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Triphasic CT

Active Comparator group

Description:

Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.

Treatment:

Procedure: Screening

Ultrasound

Active Comparator group

Description:

Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.

Treatment:

Procedure: Screening