Trial record 13 of 19 for:    Open Studies | "Dermatomyositis"

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

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01432613
First received: August 22, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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 non-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 Intervention
Myositis
Polymyositis
Dermatomyositis
Myositis, Inclusion Body
Procedure: MRI-oriented muscle biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI. [ Time Frame: between Day 0 and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Presence of IIM according to ENMC histological criteria


Secondary Outcome Measures:
  • Evaluation of ratio of positivity of non oriented versus oriented muscle biopsy [ Time Frame: every 3 months (up to 24 months) ] [ Designated as safety issue: No ]
    Evaluation of ratio of positivity (or sensitivity) of non oriented versus oriented muscle biopsy, using chi2 test.

  • Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation [ Time Frame: every 3 months (up to 24 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).


Estimated Enrollment: 325
Study Start Date: September 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Non MRI-oriented muscle biopsy
Muscle sample will be done following the usual care.
Experimental: MRI-oriented muscle biopsy
MRI-oriented muscle biopsy : muscle sample will be done where the STIR hypersignal was detected by MRI.
Procedure: MRI-oriented muscle biopsy
Orientation of muscle biopsy according to the MRI results
Other Name: MRI-oriented muscle biopsy

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.

Study calendar :

  • V1 = inclusion visit Information and non-opposition of patient Collection of demographic, clinical and biological data
  • V2 = muscle MRI Randomization
  • V3 = muscle biopsy (oriented or non-oriented) - One year after V1, collection of the final established diagnosis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, and CPK≥300 (N<170).

OR - Myalgia or muscular fatigability which is bilateral, proximal and non-objectifiable by clinical examination, and CPK≥500.

AND

-Onset of troubles ≤3 years

Exclusion Criteria:

  • Ocular muscles weakness, isolated dysarthria,
  • Patients suffering from toxic myopathy, amyloidosis, inherited muscular dystrophy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432613

Contacts
Contact: Benoît BRIHAYE, MD +33 (0) 3 22 45 53 88 benoit.brihaye@chu-amiens.fr
Contact: Raphaël SERREAU, MD, PhD +33 (0) 1 58 41 11 80 raphael.serreau@cch.aphp.fr

Locations
France
CHU Amiens Nord Recruiting
Amiens, France, 80054
Contact: Benoît BRIHAYE, MD     +33 (0)1 22 45 53 88     benoit.brihaye@chu-amiens.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Benoît BRIHAYE, MD, Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01432613     History of Changes
Other Study ID Numbers: K071204
Study First Received: August 22, 2011
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myositis
Magnetic Resonance Imaging
Muscle biopsy
Sensitivity and Specificity

Additional relevant MeSH terms:
Dermatomyositis
Muscular Diseases
Myositis
Polymyositis
Myositis, Inclusion Body
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013