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

Primary Purpose

Cirrhosis, End Stage Liver Disease, Hepatitis C

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cirrhosis focused on measuring Hepatocellular Carcinoma, Liver Cancer, Ultrasound, Computed Tomography, Alpha fetoprotein, Cirrhosis, Screening, Advanced Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minneapolis Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triphasic CT

Ultrasound

Arm Description

Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.

Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2011
Last Updated
May 23, 2011
Sponsor
Minneapolis Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01350167
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Minneapolis Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, End Stage Liver Disease, Hepatitis C
Keywords
Hepatocellular Carcinoma, Liver Cancer, Ultrasound, Computed Tomography, Alpha fetoprotein, Cirrhosis, Screening, Advanced Liver Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triphasic CT
Arm Type
Active Comparator
Arm Description
Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.
Arm Title
Ultrasound
Arm Type
Active Comparator
Arm Description
Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.
Intervention Type
Procedure
Intervention Name(s)
Screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
Description
Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Cost - Effectiveness of screening measure
Description
Cost of each screening protocol to identify one very early/early stage HCC
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Pocha, MD, PhD
Phone
612-467-4100
Email
christine.pocha@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly A McMaken, MPH
Phone
612-467-4149
Email
kelly.mcmaken@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Pocha, MD, PhD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Veterans Affairs Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Pocha, MD, PhD
Phone
612-467-4100
Email
christine.pocha@va.gov
First Name & Middle Initial & Last Name & Degree
Kelly McMaken, MPH
Phone
612-467-4149
Email
kelly.mcmaken@va.gov
First Name & Middle Initial & Last Name & Degree
Christine Pocha, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23750991
Citation
Pocha C, Dieperink E, McMaken KA, Knott A, Thuras P, Ho SB. Surveillance for hepatocellular cancer with ultrasonography vs. computed tomography -- a randomised study. Aliment Pharmacol Ther. 2013 Aug;38(3):303-12. doi: 10.1111/apt.12370. Epub 2013 Jun 10.
Results Reference
derived

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

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