CHU Amiens Nord
Amiens, 80054, France
NCT Number: NCT01432613
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Amiens, 80054, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
AND
-Onset of troubles ≤3 years
Exclusion criteria
Orientation of muscle biopsy according to the MRI results
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.
Time frame: between Day 0 and 24 months
Presence of IIM according to ENMC histological criteria
Time frame: every 3 months (up to 24 months)
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation according to ENMC (European Neuromuscular Centre) classification (calculation of Kappa coefficients).
Time frame: every 3 months (up to 24 months)
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).
Assistance Publique - Hôpitaux de Paris
Other
Acronym: DARWIM
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