Duchenne or Severe Becker MyopathyNCT02078076
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
A study testing Magnetic Resonance Cardiac Imaging (with Gadolinium) in people with Duchenne or Severe Becker Myopathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Duchenne or Severe Becker Myopathy
- What is being tested?
- Magnetic Resonance Cardiac Imaging (with Gadolinium)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Nov 2015
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dystophinopathy (Duchenne or severe Becker)
- >8yo
- with social insurance
- informed consent
Who cannot join
- arythmia
- impossibility to undergo an MRI (pacemaker, ....)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecin nucléaire / CHU Nancy Brabois
Vandœuvre-lès-Nancy
About this study
Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.
- Conditions
- Duchenne or Severe Becker Myopathy
- Being tested
- Magnetic Resonance Cardiac Imaging (with Gadolinium)
- Keywords
- MRI, free-breathing acquisitions, myopathy, fibrosis assessment, function
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Cardiac Imaging (with Gadolinium)Device
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Cardiac Imaging (with Gadolinium) | Experimental | Not described Receives: Device: Magnetic Resonance Cardiac Imaging (with Gadolinium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exams correctly acquired (feasabiliy of the exam)
Was it possible to acquire the whole examination for every patient ?
Measured: after the last inclusion
Number of exams allowing a qualitative assessment of images by the physician
The image quality allows a qualitative diagnosis ?
Measured: after the last MRI exam
Number of exams allowing a quantitative assessment of the diagnosis
Did the image quality allow a quantitative assessment of the diagnosis ?
Measured: after the last MRI examination
Secondary outcomes (2)
Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
correlation between fibrosis information (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
Measured: after the last inclusion
Number of cardiac segments with fibrosis and/or regional dysfunction
Correlation between fibrosis and regional function for each cardiac segment
Measured: after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne or Severe Becker MyopathyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078076
- Sponsor's protocol ID
- C13-04
- Other IDs
- 2013-A00179-36
- Status last verified
- Feb 2016
- First submitted
- 3 Jun 2013
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Odille F, Bustin A, Liu S, Chen B, Vuissoz PA, Felblinger J, Bonnemains L. Isotropic 3D cardiac cine MRI allows efficient sparse segmentation strategies based on 3D surface reconstruction. Magn Reson Med. 2018 May;79(5):2665-2675. doi: 10.1002/mrm.26923. Epub 2017 Oct 2.
PubMed 28971520
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
- ClinicalTrials.gov ID
- NCT02078076
- Acronym / sponsor ID
- C13-04
- Conditions
- Duchenne or Severe Becker Myopathy
- Keywords
- MRI, free-breathing acquisitions, myopathy, fibrosis assessment, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jun 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Mar 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.
Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Cardiac Imaging (with Gadolinium) | Experimental | Device: Magnetic Resonance Cardiac Imaging (with Gadolinium) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Dystophinopathy (Duchenne or severe Becker)
- >8yo
- with social insurance
- informed consent
Key exclusion criteria (2 listed)
- arythmia
- impossibility to undergo an MRI (pacemaker, ....)
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 |
|---|---|---|
| Magnetic Resonance Cardiac Imaging (with Gadolinium) | Device | Magnetic Resonance Cardiac Imaging (with Gadolinium) |
Primary outcome
Number of exams correctly acquired (feasabiliy of the exam)
Time frame: after the last inclusion
Was it possible to acquire the whole examination for every patient ?
Number of exams allowing a qualitative assessment of images by the physician
Time frame: after the last MRI exam
The image quality allows a qualitative diagnosis ?
Number of exams allowing a quantitative assessment of the diagnosis
Time frame: after the last MRI examination
Did the image quality allow a quantitative assessment of the diagnosis ?
2 secondary outcomes
Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
Time frame: after the last inclusion
Number of cardiac segments with fibrosis and/or regional dysfunction
Time frame: after the last inclusion
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 27 Aug 2025.
- Results publication: PubMed 28971520Odille F, Bustin A, Liu S, Chen B, Vuissoz PA, Felblinger J, Bonnemains L. Isotropic 3D cardiac cine MRI allows efficient sparse segmentation strategies based on 3D surface reconstruction. Magn Reson Med. 2018 May;79(5):2665-2675. doi: 10.1002/mrm.26923. Epub 2017 Oct 2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Cardiac Imaging (with Gadolinium) in people with Duchenne or Severe Becker Myopathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 2 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of exams correctly acquired (feasabiliy of the exam) (time frame: after the last inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078076, which also lists 1 linked publication.
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 27 Aug 2025.