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NCT Number: NCT01113814

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

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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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FibroScan

Device

Acoustic Radiation Force Impulse (ARFI)- Imaging

Device

Primary outcomes

  1. 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 outcomes

  1. Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker)

  2. Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF)

  3. Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis

  4. Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography

  5. Assessment of center variability of results

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

First posted
Apr 30, 2010
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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