MyositisDARWIMNCT01432613
Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
A study testing MRI-oriented muscle biopsy in people with Myositis and Polymyositis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myositis, Polymyositis, Dermatomyositis
- What is being tested?
- MRI-oriented muscle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2010to 26 Nov 2016
- 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
- Skin rash typical of dermatomyositis: "lilac" rash (+/- oedemata) of upper eyelids, periungual sign, erythematous-scaly eruption occurring over the MCP and IPP, elbow, knees (Gottron's signs ands papules), erythema of light-sensitive areas OR
- Muscle weakness which is proximal, bilateral and objectifiable by clinical examination ≤ 4/5, and CPK≥2N (N<170).
- Increase CPK and presence of acquired myositis specific antibody
- AND
- -Onset of troubles ≤3 years
Who cannot join
- Pregnant female
- Proximal motive neuropathy
- Refusing participation
- Patient under 18 years old
- Adult patient under legal protection
- Patient with contraindication for MRI, pacemaker
Show all 9Show fewer
- For all other magnetic or ironic implanted equipments, metal workers, must contact PI to ensure their eligibility
- Ocular muscles weakness, isolated dysarthria,
- Patients suffering from toxic myopathy, amyloidosis, inherited muscular dystrophy
Trial locations and contacts
1 site in 1 country.
About this study
Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The main aim of this interventional study is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.
Read the detailed description
Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and as a specific treatment is needed (corticosteroids, immunosuppressant, and "biotherapies").
Currently the use of muscle MRI in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. Some systematically order a muscle MRI for patients suspected to suffer from IIM, others hold this examination for patients selected according to non defined criteria, and others sometimes use MRI to follow-up patients. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The results published in the great majority of studies are obtained with patients whose IIM diagnosis is already established. The diagnostic accuracy of muscle MRI in real conditions of clinical practice is thus unknown for patients having a simple suspicion of IIM.
Primary scientific aim: Evaluation of diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.
Secondary scientific aim: Comparison of two diagnostic strategies: MRI-oriented muscle biopsy versus non MRI-oriented muscle biopsy.
Gold standard: muscle biopsy Index test: whole body MRI, STIR and T1 sequences Patients and setting of diagnosis tests: Screening will be realized on any patient suspected to suffer from inflammatory and addressed for muscle biopsy in one of the participating reference centres for neuro-muscular disorders. -Evaluate if RMI is efficiency to reduce false negative results during a second biopsy.
- Evaluation of reproducibility inter-observers and intra-observers of interpretations of RMI.
- Evaluation of reproducibility inter-observers and intra-observers of muscles biopsy interpretations according with the European neuro muscular classification ENMC.
Study calendar :
- Including 130 patients during 24 months
- RMI interpretations are realised immediately after RMI exam without informing the investigator.
- Procedures of anonymisation of the double reading are done every 03 months.
- V1 = inclusion visit Information and non-opposition of patient Collection of demographic, clinical and biological data
- V2 = muscle MRI
- V3 = muscle biopsy
- One year after V1, collection of the final established diagnosis and compare it to the investigator results
- Conditions
- Myositis, Polymyositis, Dermatomyositis, Myositis, Inclusion Body
- Being tested
- MRI-oriented muscle biopsy
- Keywords
- Myositis, Magnetic Resonance Imaging, Muscle biopsy, Sensitivity and Specificity
- Medical subject headings
- Myositis, Polymyositis, Dermatomyositis, Myositis, Inclusion Body, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-oriented muscle biopsyProcedure or surgery
Orientation of muscle biopsy according to the MRI results
| Study group | Role | What they receive |
|---|---|---|
| MRI-oriented muscle biopsy | Other | Muscle sample will be done following the usual care. Receives: Procedure: MRI-oriented muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI.
Description : diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for the diagnostic of inflammatory myopathy.
Measured: between Day 0 and 24 months
Presence of IIM diagnosed by muscle biopsy
Presence of IIM according to ENMC histological criteria
Measured: between Day 0 and 24 months
Secondary outcomes (2)
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation according to ENMC (European Neuromuscular Centre) classification (calculation of Kappa coefficients).
Measured: every 3 months (up to 24 months)
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).
Measured: every 3 months (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study start22 Dec 2010
- Primary completion11 Feb 2016
- Study completion26 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yves ALLENBACH, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432613
- Sponsor's protocol ID
- K071204
- Acronym
- DARWIM
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2011
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
- ClinicalTrials.gov ID
- NCT01432613
- Acronym / sponsor ID
- DARWIM / K071204
- Conditions
- Myositis, Polymyositis, Dermatomyositis, Myositis, Inclusion Body
- Keywords
- Myositis, Magnetic Resonance Imaging, Muscle biopsy, Sensitivity and Specificity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 22 Dec 2010 (actual)
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 26 Nov 2016 (actual)
- First posted
- 13 Sep 2011 (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.
Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and a specific treatment is needed. Currently the use of muscle MRI (magnetic resonance imaging) in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The main aim of this interventional study is to evaluate the diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.
Detailed description
Idiopathic inflammatory myopathies (IIM) are a great concern in acquired muscle illnesses. An appropriate and rapid diagnosis is necessary, because morbidity and mortality are high and as a specific treatment is needed (corticosteroids, immunosuppressant, and "biotherapies").
Currently the use of muscle MRI in departments managing IIM is common. In absence of recommendations fixing their place in the diagnostic phase, the practices observed are extremely heterogeneous. Some systematically order a muscle MRI for patients suspected to suffer from IIM, others hold this examination for patients selected according to non defined criteria, and others sometimes use MRI to follow-up patients. This practices diversity well reflects the lack of data in the literature, making it impossible to appreciate the real contribution of this test. The results published in the great majority of studies are obtained with patients whose IIM diagnosis is already established. The diagnostic accuracy of muscle MRI in real conditions of clinical practice is thus unknown for patients having a simple suspicion of IIM.
Primary scientific aim: Evaluation of diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for patients who are suspected to suffer from IIM.
Secondary scientific aim: Comparison of two diagnostic strategies: MRI-oriented muscle biopsy versus non MRI-oriented muscle biopsy.
Gold standard: muscle biopsy Index test: whole body MRI, STIR and T1 sequences Patients and setting of diagnosis tests: Screening will be realized on any patient suspected to suffer from inflammatory and addressed for muscle biopsy in one of the participating reference centres for neuro-muscular disorders. -Evaluate if RMI is efficiency to reduce false negative results during a second biopsy.
- Evaluation of reproducibility inter-observers and intra-observers of interpretations of RMI.
- Evaluation of reproducibility inter-observers and intra-observers of muscles biopsy interpretations according with the European neuro muscular classification ENMC.
Study calendar :
- Including 130 patients during 24 months
- RMI interpretations are realised immediately after RMI exam without informing the investigator.
- Procedures of anonymisation of the double reading are done every 03 months.
- V1 = inclusion visit Information and non-opposition of patient Collection of demographic, clinical and biological data
- V2 = muscle MRI
- V3 = muscle biopsy
- One year after V1, collection of the final established diagnosis and compare it to the investigator results
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-oriented muscle biopsy | Other | Procedure: MRI-oriented muscle biopsyMuscle sample will be done following the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Skin rash typical of dermatomyositis: "lilac" rash (+/- oedemata) of upper eyelids, periungual sign, erythematous-scaly eruption occurring over the MCP and IPP, elbow, knees (Gottron's signs ands papules), erythema of light-sensitive areas OR
- Muscle weakness which is proximal, bilateral and objectifiable by clinical examination ≤ 4/5, and CPK≥2N (N<170).
- Increase CPK and presence of acquired myositis specific antibody
- AND
- -Onset of troubles ≤3 years
Key exclusion criteria (9 listed)
- Pregnant female
- Proximal motive neuropathy
- Refusing participation
- Patient under 18 years old
- Adult patient under legal protection
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 |
|---|---|---|
| MRI-oriented muscle biopsyOrientation of muscle biopsy according to the MRI results | Procedure or surgery | MRI-oriented muscle biopsy |
Primary outcome
Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI.
Time frame: between Day 0 and 24 months
Description : diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for the diagnostic of inflammatory myopathy.
Presence of IIM diagnosed by muscle biopsy
Time frame: between Day 0 and 24 months
Presence of IIM according to ENMC histological criteria
2 secondary outcomes
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation
Time frame: every 3 months (up to 24 months)
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation
Time frame: every 3 months (up to 24 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 31 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Yves ALLENBACH, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-oriented muscle biopsy in people with Myositis and Polymyositis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 9 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 31 Mar 2026. 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?
Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI. (time frame: between Day 0 and 24 months). The study lists 2 primary outcomes in all. 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 31 Mar 2026.