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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.
Sponsor:
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01113814
First received: April 27, 2010
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113814

Locations
France
Bordeaux University Hospital
Bordeaux, France
Germany
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
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Johannes Vermehren, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01113814     History of Changes
Other Study ID Numbers: JWGUHMED1-003
Study First Received: April 27, 2010
Last Updated: May 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Hepatitis C, Chronic
Pathologic Processes
 Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013