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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Device: FibroScan
* Device: Acoustic Radiation Force Impulse (ARFI)- Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FibroScan|nan|
|Device: Acoustic Radiation Force Impulse (ARFI)- Imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |