We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432613
First Posted: September 13, 2011
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
August 22, 2011
September 13, 2011
June 28, 2016
September 2010
June 2016   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01432613 on ClinicalTrials.gov Archive Site
  • 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).
  • Evaluation of ratio of positivity of non oriented versus oriented muscle biopsy [ Time Frame: every 3 months (up to 24 months) ]
    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) ]
    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).
Not Provided
Not Provided
 
Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
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.

  • 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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Myositis
  • Polymyositis
  • Dermatomyositis
  • Myositis, Inclusion Body
Procedure: MRI-oriented muscle biopsy
Orientation of muscle biopsy according to the MRI results
MRI-oriented muscle biopsy
Muscle sample will be done following the usual care.
Intervention: Procedure: MRI-oriented muscle biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
139
December 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01432613
K071204
No
Not Provided
Plan to Share IPD: No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Yves ALLENBACH, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP