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

Hepatitis C Clinical Trial

Official title:

Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01350167
• Other study ID #: 3034-A
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2011
• Last updated: May 23, 2011
• Start date: November 2001
• Est. completion date: December 2021

Study information

• Verified date: December 2010
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: Christine Pocha, MD, PhD
• Phone: 612-467-4100
• Email: christine.pocha[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis
• End Stage Liver Disease
• Hepatitis C
• Liver Diseases

Intervention

Procedure:
• Screening
Triphasic CT of the abdomen with and without contrast every 12 months and alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years. Ultrasound of the upper left quadrant every 6 months with alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.

Locations

Country	Name	City	State
United States	Minneapolis Veterans Affairs Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)	Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations	6-12 months	No
Secondary	Cost - Effectiveness of screening measure	Cost of each screening protocol to identify one very early/early stage HCC	1 year	No