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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-oriented muscle biopsy | Other | Muscle sample will be done following the usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-oriented muscle biopsy | Procedure | Orientation of muscle biopsy according to the MRI results |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between Day 0 and 24 months |
| Presence of IIM diagnosed by muscle biopsy | Presence of IIM according to ENMC histological criteria | between Day 0 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | every 3 months (up to 24 months) |
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Inclusion Criteria:
AND
-Onset of troubles ≤3 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves ALLENBACH, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Nord | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| D009220 | Myositis |
| D017285 | Polymyositis |
| D003882 | Dermatomyositis |
| D018979 | Myositis, Inclusion Body |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 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). |
| every 3 months (up to 24 months) |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D007154 | Immune System Diseases |