Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for Liver Fibrosis Staging in HCV
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
1 other identifier
interventional
N/A
3 countries
9
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.
Trial Health
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9 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedMay 22, 2012
May 1, 2012
April 27, 2010
May 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Consuming illness (HIV infection, malignoma)
- Comorbidities associated to HCV (HBV, NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis
- Pacemaker or heart defibrillator
- Pregnancy or lactation
- Liver transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Bordeaux University Hospital
Bordeaux, France
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Klinikum der J.W. Goethe-Universität
Frankfurt am Main, Germany
Institut für Interdisziplinäre Medizin
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern
München, Germany
Erasmus Medical Center
Rotterdam, Netherlands