Liver Fibrosis Assessment With ShearWave Elastography

May 11, 2015 updated by: SuperSonic Imagine

Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases

Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver.

This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

Study Overview

Status

Completed

Conditions

Detailed Description

The measurements of liver stiffness made by the Aixplorer® will be compared to (where available) :

  • blood markers
  • biopsy results
  • other stiffness measurement exams (FibroScan, ARFI, ElastPQ...)

The influence of other (confounding) factors on the reliability of SWE measurements will be analyzed.

Study Type

Observational

Enrollment (Actual)

2333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium
        • University of Antwerp
  • China
      • Guangzhou, Guangdong, China
        • 3rd Hospital of Sun Yat-sen University
  • Denmark
      • Odense, Denmark
        • Odense University hospital
  • France
      • Bordeaux, France
        • University Hospital of Bordeaux
      • Clichy, France
        • Beaujon Hospital
      • Lyon, France
        • Hôpital Edouard Herriot
      • Paris, France
        • Cochin Hospital
  • Germany
      • Bonn, Germany
        • University of Bonn
      • Frankfurt, Germany
        • Johan Goethe Universitat
  • Greece
      • Athens, Greece
        • University of Athens Medical School
  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong Kong - Prince of Wales Hospital
  • Italy
      • Pavia, Italy
        • University of Pavia
  • Romania
      • Timisoara, Romania
        • University of Timosoara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population will consist of patients who have confirmed or suspected liver fibrosis and will be assessed with ultrasound, +/- blood analysis, +/- other non-invasive imaging, and/or measurements, and biopsy

Description

Inclusion Criteria:

  • Patients meeting a single condition below:

    • Chronic hepatitis B, defined by serology HBsAg positive and the presence of DNA / RNA in the serum, or
    • Chronic hepatitis C, defined by serology anti-HCV positive and the presence of DNA / RNA in the serum, or
    • non-alcoholic fatty-liver disease

  • And meeting all of the conditions below:

    • liver biopsy for histological evaluation of liver fibrosis
    • Length of liver biopsy ≥ 15 mm paraffin sections (except if cirrhosis)
    • Age of majority in their country
    • Obtaining the signature of consent for participation in the data collection, in addition to the routine consent form routinely used at the sites.

Exclusion Criteria:

  • Cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic fatty-liver disease
  • History of antiviral therapy for 6 months or less of current antiviral therapy
  • Any systemic, viral hepatitis and HIV co-infection
  • Pregnant woman
  • Failure to obtain consent
  • Length of all liver biopsy specimens below 15mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation coefficients between factors and liver stiffness
Time Frame: Within one year of the study start date
Factors include patient's clinical and biological parameters
Within one year of the study start date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rates depending on factors
Time Frame: Within one year of the study start date
Factors include patient's clinical and biological parameters
Within one year of the study start date
Diagnostic performance of multivariate models to assess liver fibrosis levels
Time Frame: Within one year of the study start date

Determined by histological examination of liver biopsy. The resulting tests will be compared on the basis of their AUROC and test of statistical differences.

Fibrosis levels involved are:

  • at least significant fibrosis (Metavir score F≥2)
  • at least severe fibrosis (Metavir score F≥3)
  • liver cirrhosis (Metavir score F=4)
Within one year of the study start date
Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis
Time Frame: Within one year of the study start date
This will be determined by histological examination of liver biopsy
Within one year of the study start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperSonic Imagine

Collaborators

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Mireen Freidrich-Rust, Johan Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 4, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LE1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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