Clinical trial NCT01113814: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis C
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-04-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker)
measure: Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF)
measure: Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis
measure: Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography
measure: Assessment of center variability of results
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Klinikum der J.W. Goethe-Universität
city: Hamburg
country: Germany
facility: Institut für Interdisziplinäre Medizin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: