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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibroScan | Device | |||
| Acoustic Radiation Force Impulse (ARFI)- Imaging | Device |
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | France | ||||
| Universitätsklinikum Düsseldorf |
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| 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 |
| 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 | Hanover | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern | München | Germany |
| Erasmus Medical Center | Rotterdam | Netherlands |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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