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

Not Applicable

• Conditions: Cirrhosis; Hepatitis C; End Stage Liver Disease
• Interventions: Procedure: Screening

• Registration Number: NCT01350167
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-11
• Status Verified: 2010-12
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Last Update Submitted: 2011-05-23
• Last Update Posted: 2011-05-24
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triphasic CT	Screening	Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.
Ultrasound	Screening	Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.

Primary Outcome Measures

Name	Time	Method
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)	6-12 months	Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations

Secondary Outcome Measures

Name	Time	Method
Cost - Effectiveness of screening measure	1 year	Cost of each screening protocol to identify one very early/early stage HCC

Trial Locations

Locations (1)

Minneapolis Veterans Affairs Medical Center; 🇺🇸 Minneapolis, Minnesota, United States