Liver FibrosisNCT02181452
Liver Fibrosis Assessment With ShearWave Elastography
An observational study of Liver Fibrosis, run by SuperSonic Imagine at 13 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis
- How many people
- 2,333 participants
- Where
- 13 sitesin 9 countries
- Study dates
- Nov 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
13 sites in 9 countries.
13 sites in 9 countries
France4 sites
University Hospital of Bordeaux
Bordeaux
Beaujon Hospital
Clichy
Hopital Edouard Herriot
Lyon
Cochin Hospital
Paris
Hong Kong1 site
Chinese University of Hong Kong - Prince of Wales Hospital
Hong Kong
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Fibrosis
- Keywords
- liver, fibrosis, ShearWave Elastography, ultrasound
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients between factors and liver stiffness
Factors include patient's clinical and biological parameters
Measured: Within one year of the study start date
Secondary outcomes (3)
Technical success rates depending on factors
Factors include patient's clinical and biological parameters
Measured: Within one year of the study start date
Diagnostic performance of multivariate models to assess liver fibrosis levels
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)
Measured: Within one year of the study start date
Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis
This will be determined by histological examination of liver biopsy
Measured: Within one year of the study start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Responsible party
- Sponsor
- Investigators
- Mireen Freidrich-Rust, Principal investigator, Johan Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181452
- Sponsor's protocol ID
- LE1
- Status last verified
- May 2015
- First submitted
- 19 Jun 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases
- ClinicalTrials.gov ID
- NCT02181452
- Acronym / sponsor ID
- LE1
- Conditions
- Liver Fibrosis
- Keywords
- liver, fibrosis, ShearWave Elastography, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,333 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- Patients meeting a single condition below:
- And meeting all of the conditions below:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Technical success rates depending on factors
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireen Freidrich-Rust principal investigator
Johan Goethe University
13 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by SuperSonic Imagine at 13 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Germany, Belgium, China, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficients between factors and liver stiffness (time frame: Within one year of the study start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.