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

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Chronic Hepatitis C

Treatments: Device: Acoustic Radiation Force Impulse (ARFI)- Imaging; Device: FibroScan

Study type: Interventional

Funder types: Other

Identifiers

NCT01113814

JWGUHMED1-003

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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