View Clinical Trial (Medical Research Study)
Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
| City: |
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Minneapolis |
| State: |
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Minnesota |
| Zip Code: |
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55417 |
| Conditions: |
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Cirrhosis - End Stage Liver Disease - Hepatitis C |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01350167 |
| Primary Contact: |
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Principal Investigator
Christine Pocha, MD, PhD
Minneapolis Veterans Affairs Medical Center
Christine Pocha, MD, PhD
Phone: 612-467-4100
Email: christine.pocha@va.gov
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| Backup Contact: |
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Email: kelly.mcmaken@va.gov
Kelly A McMaken, MPH
Phone: 612-467-4149
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| Location Contact: |
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Minneapolis, Minnesota 55417
United States
Christine Pocha, MD, PhD
Phone: 612-467-4100
Email: christine.pocha@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
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