Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for Liver Fibrosis Staging in HCV
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ClinicalTrials.gov Identifier: NCT01113814
: April 30, 2010
Last Update Posted
: May 22, 2012
Johann Wolfgang Goethe University Hospital
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospitals
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 or disease
Chronic Hepatitis C
Device: FibroScanDevice: Acoustic Radiation Force Impulse (ARFI)- Imaging
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
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female, 18-79 years old
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