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Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for Liver Fibrosis Staging in HCV

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FibroScan
Acoustic Radiation Force Impulse (ARFI)- Imaging
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, 18-79 years old
  • Written consent
  • Chronic Hepatitis C infection
  • Liver biopsy planned or performed within the last six months
  • In addition, 10 patients/center with proven liver cirrhosis without present liver biopsy can be included

Exclusion Criteria:

  • Consuming illness (HIV infection, malignoma)
  • Comorbidities associated to HCV (HBV, NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis
  • Antiviral therapy between liver biopsy and study inclusion
  • Pacemaker or heart defibrillator
  • Pregnancy or lactation
  • Liver transplantation

Sites / Locations

  • Bordeaux University Hospital
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Erlangen
  • Klinikum der J.W. Goethe-Universität
  • Institut für Interdisziplinäre Medizin
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Leipzig
  • Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern
  • Erasmus Medical Center

Outcomes

Primary Outcome Measures

Non-inferiority of AUROCs of Acoustic Radiation Force Impulse (ARFI)- Imaging to Transient Elastography (Fibroscan) for assessment of liver fibrosis in patients with chronic hepatitis C using liver biopsy as the reference standard.
The diagnostic accuracy measured with the Area under the ROC curve (AUROC) is calculated for Acoustic Radiation Force Impulse (ARFI)- Imaging and Transient Elastography (Fibroscan) using histology obtained by liver biopsy as reference method in patients infected with chronic hepatitis C. The ROC curve represents sensitivity versus 1-specificity for all possible cut-off values for prediction of the different fibrosis stages, respectively. The areas under the curves (AUROC) as well as 95 % CI of AUROC are calculated.

Secondary Outcome Measures

Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker)
Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF)
Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis
Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography
Assessment of center variability of results

Full Information

First Posted
April 27, 2010
Last Updated
May 21, 2012
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01113814
Brief Title
Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for Liver Fibrosis Staging in HCV
Official Title
Performance of Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for the Non-invasive Staging of Liver Fibrosis in Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)- Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference method. The target sample size is 433.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
FibroScan
Intervention Type
Device
Intervention Name(s)
Acoustic Radiation Force Impulse (ARFI)- Imaging
Primary Outcome Measure Information:
Title
Non-inferiority of AUROCs of Acoustic Radiation Force Impulse (ARFI)- Imaging to Transient Elastography (Fibroscan) for assessment of liver fibrosis in patients with chronic hepatitis C using liver biopsy as the reference standard.
Description
The diagnostic accuracy measured with the Area under the ROC curve (AUROC) is calculated for Acoustic Radiation Force Impulse (ARFI)- Imaging and Transient Elastography (Fibroscan) using histology obtained by liver biopsy as reference method in patients infected with chronic hepatitis C. The ROC curve represents sensitivity versus 1-specificity for all possible cut-off values for prediction of the different fibrosis stages, respectively. The areas under the curves (AUROC) as well as 95 % CI of AUROC are calculated.
Secondary Outcome Measure Information:
Title
Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker)
Title
Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF)
Title
Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis
Title
Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography
Title
Assessment of center variability of results

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 18-79 years old Written consent Chronic Hepatitis C infection Liver biopsy planned or performed within the last six months In addition, 10 patients/center with proven liver cirrhosis without present liver biopsy can be included Exclusion Criteria: Consuming illness (HIV infection, malignoma) Comorbidities associated to HCV (HBV, NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis Antiviral therapy between liver biopsy and study inclusion Pacemaker or heart defibrillator Pregnancy or lactation Liver transplantation
Facility Information:
Facility Name
Bordeaux University Hospital
City
Bordeaux
Country
France
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Klinikum der J.W. Goethe-Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Institut für Interdisziplinäre Medizin
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern
City
München
Country
Germany
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for Liver Fibrosis Staging in HCV

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