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

This study is currently recruiting participants.
Verified December 2010 by Minneapolis Veterans Affairs Medical Center
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01350167
First received: May 3, 2011
Last updated: May 23, 2011
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention
Cirrhosis
End Stage Liver Disease
Hepatitis C
 Procedure: Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System) [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations


Secondary Outcome Measures:
  • Cost - Effectiveness of screening measure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cost of each screening protocol to identify one very early/early stage HCC


Estimated Enrollment: 300
Study Start Date: November 2001
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triphasic CT
Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.
 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.
Active Comparator: Ultrasound
Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350167

Contacts
Contact: Christine Pocha, MD, PhD 612-467-4100 christine.pocha@va.gov
Contact: Kelly A McMaken, MPH 612-467-4149 kelly.mcmaken@va.gov

Locations
United States, Minnesota
Minneapolis Veterans Affairs Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Christine Pocha, MD, PhD     612-467-4100     christine.pocha@va.gov    
Contact: Kelly McMaken, MPH     612-467-4149     kelly.mcmaken@va.gov    
Principal Investigator: Christine Pocha, MD, PhD            
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Christine Pocha, MD, PhD Minneapolis Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Christine Pocha/Staff Physician, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT01350167     History of Changes
Other Study ID Numbers: 3034-A
Study First Received: May 3, 2011
Last Updated: May 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Hepatocellular Carcinoma
Liver Cancer
Ultrasound
Computed Tomography
 Alpha fetoprotein
Cirrhosis
Screening
Advanced Liver Disease

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Failure
Hepatic Insufficiency
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013