Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies (DARWIM)
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|ClinicalTrials.gov Identifier: NCT01432613|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myositis Polymyositis Dermatomyositis Myositis, Inclusion Body||Procedure: MRI-oriented muscle biopsy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies|
|Actual Study Start Date :||December 22, 2010|
|Actual Primary Completion Date :||February 11, 2016|
|Actual Study Completion Date :||November 26, 2016|
MRI-oriented muscle biopsy
Muscle sample will be done following the usual care.
Procedure: MRI-oriented muscle biopsy
Orientation of muscle biopsy according to the MRI results
- 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
- 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 biopsy interpretation according to ENMC (European Neuromuscular Centre) classification (calculation of Kappa coefficients).
- Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation [ Time Frame: every 3 months (up to 24 months) ]Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432613
|CHU Amiens Nord|
|Amiens, France, 80054|
|Principal Investigator:||Yves ALLENBACH, MD, PhD||Assistance Publique - Hôpitaux de Paris|