DARWIM: Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01432613

Collaborator

(none)

139

Enrollment

Location

Arm

71.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Myositis Polymyositis Dermatomyositis Myositis, Inclusion Body	Procedure: MRI-oriented muscle biopsy	N/A

Detailed Description

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

Study Type:

Interventional

Actual Enrollment :

139 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

Actual Study Start Date :

Dec 22, 2010

Actual Primary Completion Date :

Feb 11, 2016

Actual Study Completion Date :

Nov 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI. [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 [between Day 0 and 24 months]
Presence of IIM according to ENMC histological criteria

Secondary Outcome Measures

Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation [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 [every 3 months (up to 24 months)]
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant female
Proximal motive neuropathy
Refusing participation
Patient under 18 years old
Adult patient under legal protection
Patient with contraindication for MRI, pacemaker
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