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

Not Applicable

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT01113814
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (9)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Institut für Interdisziplinäre Medizin; 🇩🇪 Hamburg, Germany

Klinikum der J.W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern; 🇩🇪 München, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany