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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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: August 1, 2013
Last verified: July 2013
  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 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: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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 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: 130
Study Start Date: September 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (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.
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. -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
  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 ≤ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432613

Contacts
Contact: Yves ALLENBACH, MD, PhD +33 3 22 45 53 88 yves.allenbach@psl.aphp.fr
Contact: Laurence Lecomte, PhD laurence.lecomte@nck.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: Yves ALLENBACH, MD, PhD 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: August 1, 2013
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 July 23, 2014