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

This study has been completed.
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals Identifier:
First received: April 27, 2010
Last updated: May 21, 2012
Last verified: May 2012
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.

Condition Intervention
Chronic Hepatitis C
Device: FibroScan
Device: Acoustic Radiation Force Impulse (ARFI)- Imaging

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Johann Wolfgang Goethe University Hospital:

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


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01113814

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
Hannover, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern
München, Germany
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals Identifier: NCT01113814     History of Changes
Other Study ID Numbers: JWGUHMED1-003
Study First Received: April 27, 2010
Last Updated: May 21, 2012

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections processed this record on April 28, 2017