Chronic Liver DiseaseNCT03704792
Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference
A study testing FibroScan 530 Compact in people with Chronic Liver Disease, run by Echosens at 5 sites in France.
Trial summary
Chronic liver diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases. CLD is most of the time an asymptomatic, progressive, and potentially fatal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- FibroScan 530 Compact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 5 sitesFrance
- Study dates
- 24 Sep 2019to 30 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patient must be at least 18 years of age
- Patient must be able to give written informed consent
- Patient affiliated to a social security system
- Patient with a chronic liver disease, all etiologies
Who cannot join
- Vulnerable patient
- Pregnant women
- Patient with presence of ascites
- Contra-indication to MRI
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Universitaire d'Angers
Angers
Hôpitaux Universitaires Paris Seine Saint-Denis - Service Hépatologie
Bondy, 93140
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque
Bordeaux
Hôpital Saint-Antoine - Service Hépatologie
Paris, 75012
CHU Rennes Hôpital Pontchaillou - Service des Maladies du Foie
Rennes, 35033
About this study
Chronic liver diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases. CLD is most of the time an asymptomatic, progressive, and potentially fatal disease. With its complications it becomes one of the major causes of mortality worldwide. Globally, hepatitis B virus and hepatitis C virus, alcoholic liver disease and non-alcoholic steatohepatitis, are the most important causes of liver disease.
The diagnosis of liver lesions remains an important issue for these patients. The prognosis and management of liver disease greatly depends on the amount of liver fibrosis. In early stages, it is the main factor predicting long-term outcome of these patients. The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment, although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy. It includes direct and indirect serum markers of liver fibrosis, but also several imaging-based methods, including transient elastography (FibroScan®, Echosens, Paris, France).
Read more
Even if the liver fibrosis is the key pathological feature of progressive liver disease, the accumulation of excessive hepatic triglyceride, hepatic steatosis, is today recognized as an important factor in the pathogenesis of a number of CLD. The magnetic resonance imaging (MRI) techniques are sensitive to steatosis and show interesting diagnostic performances, especially the MRI using the proton density fat fraction (MRI-PDFF) which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy and with histological grade, across several studies. Therefore, this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis. Echosens has developed an ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™).
Echosens is working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan. This protocol is set-up to compare the diagnostic performances of the first generation of the CAP and the second generation of the CAP to the reference, the MRI-PDFF, in patients with CLD, all etiologies combined.
- Conditions
- Chronic Liver Disease
- Being tested
- FibroScan 530 Compact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScan 530 CompactDevice
The FibroScan® is a device equipped with probes (M+ or XL+), each of which consists of an ultrasonic transducer mounted on the axis of a mechanical vibrator. Liver stiffness and CAP measurements are performed on the right lobe of the liver with the patient in a dorsal decubitus and maximal abduction position. The procedure is non-invasive and painless.
| Study group | Role | What they receive |
|---|---|---|
| Adult CLD Group | Experimental | Only one group of patients in the study: adult patients with chronic liver disease (CLD), all etiologies combined, who will have a FibroScan 530 Compact examination to calculate the CAP value. Receives: Device: FibroScan 530 Compact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content assessed by MRI-PDFF.
Measured: 12 months
Secondary outcomes (3)
Ratio IQR CAPv1/CAPv2 and/or ratio standard deviation CAPv1/CAPv2
Measured: 12 months
Difference between CAPv1 and CAPv2 measures
Measured: 12 months
Correlation between CAPv1, CAPv2 and MRI-PDFF
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start24 Sep 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosens
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704792
- Sponsor's protocol ID
- M134
- Status last verified
- Aug 2022
- First submitted
- 10 Oct 2018
- Last updated
- 8 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference
- ClinicalTrials.gov ID
- NCT03704792
- Acronym / sponsor ID
- M134
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- EchosensIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 15 Oct 2018 (actual)
- 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 diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases. CLD is most of the time an asymptomatic, progressive, and potentially fatal disease. With its complications it becomes one of the major causes of mortality worldwide. Globally, hepatitis B virus and hepatitis C virus, alcoholic liver disease and non-alcoholic steatohepatitis, are the most important causes of liver disease.
The diagnosis of liver lesions remains an important issue for these patients. The prognosis and management of liver disease greatly depends on the amount of liver fibrosis. In early stages, it is the main factor predicting long-term outcome of these patients. The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment, although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy. It includes direct and indirect serum markers of liver fibrosis, but also several imaging-based methods, including transient elastography (FibroScan®, Echosens, Paris, France).
Even if the liver fibrosis is the key pathological feature of progressive liver disease, the accumulation of excessive hepatic triglyceride, hepatic steatosis, is today recognized as an important factor in the pathogenesis of a number of CLD. The magnetic resonance imaging (MRI) techniques are sensitive to steatosis and show interesting diagnostic performances, especially the MRI using the proton density fat fraction (MRI-PDFF) which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy and with histological grade, across several studies. Therefore, this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis. Echosens has developed an ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™).
Echosens is working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan. This protocol is set-up to compare the diagnostic performances of the first generation of the CAP and the second generation of the CAP to the reference, the MRI-PDFF, in patients with CLD, all etiologies combined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult CLD Group | Experimental | Device: FibroScan 530 CompactOnly one group of patients in the study: adult patients with chronic liver disease (CLD), all etiologies combined, who will have a FibroScan 530 Compact examination to calculate the CAP value. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be at least 18 years of age
- Patient must be able to give written informed consent
- Patient affiliated to a social security system
- Patient with a chronic liver disease, all etiologies
Key exclusion criteria (4 listed)
- Vulnerable patient
- Pregnant women
- Patient with presence of ascites
- Contra-indication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroScan 530 CompactThe FibroScan® is a device equipped with probes (M+ or XL+), each of which consists of an ultrasonic transducer mounted on the axis of a mechanical vibrator. Liver stiffness and CAP measurements are performed on the right lobe of the liver with the patient in a dorsal decubitus and maximal abduction position. The procedure is non-invasive and painless. | Device | Adult CLD Group |
Primary outcome
Liver fat content assessed by MRI-PDFF.
Time frame: 12 months
3 secondary outcomes
Ratio IQR CAPv1/CAPv2 and/or ratio standard deviation CAPv1/CAPv2
Time frame: 12 months
Difference between CAPv1 and CAPv2 measures
Time frame: 12 months
Correlation between CAPv1, CAPv2 and MRI-PDFF
Time frame: 12 months
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 8 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan 530 Compact in people with Chronic Liver Disease, run by Echosens at 5 sites in France.
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 4 inclusion and 4 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 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Liver fat content assessed by MRI-PDFF. (time frame: 12 months). 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 8 Aug 2022.