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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

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.

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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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FibroScan

Intervention Type DEVICE

Acoustic Radiation Force Impulse (ARFI)- Imaging

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No