Have you or your loved ones been diagnosed with cirrhosis?

You may be eligible to participate in a cirrhosis clinical trial.

Have you or your loved ones been diagnosed with cirrhosis? You may be eligible to participate in a cirrhosis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Cirrhosis Clinical Trial in Minneapolis MN

NCT01350167 | Interventional

Have you or your loved ones been diagnosed with cirrhosis?

You may be eligible to participate in a cirrhosis clinical trial.

Have you or your loved ones been diagnosed with cirrhosis? You may be eligible to participate in a cirrhosis clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 300 Participants

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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Details for the study

Brief Title

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

Official Title

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

Brief Summary

The purpose of this study is to determine whether ultrasound or CT scanning is more effective<br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Secondary

Cost - Effectiveness of screening measure

Cost of each screening protocol to identify one very early/early stage HCC

1 year

Study 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