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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113814
• Other study ID #: JWGUHMED1-003
• Status: Completed
• Phase: N/A
• First received: April 27, 2010
• Last updated: May 21, 2012

Study information

• Verified date: May 2012
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Device:
• FibroScan

• Acoustic Radiation Force Impulse (ARFI)- Imaging

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux
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
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker)
Secondary	Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF)
Secondary	Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis
Secondary	Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography
Secondary	Assessment of center variability of results