Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies (DARWIM)
Primary Purpose
Myositis, Polymyositis, Dermatomyositis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI-oriented muscle biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Myositis focused on measuring Myositis, Magnetic Resonance Imaging, Muscle biopsy, Sensitivity and Specificity
Eligibility 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
Sites / Locations
- CHU Amiens Nord
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI-oriented muscle biopsy
Arm Description
Muscle sample will be done following the usual care.
Outcomes
Primary Outcome Measures
Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI.
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
Presence of IIM according to ENMC histological criteria
Secondary Outcome Measures
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation
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
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).
Full Information
NCT ID
NCT01432613
First Posted
August 22, 2011
Last Updated
March 1, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01432613
Brief Title
Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
Acronym
DARWIM
Official Title
Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 22, 2010 (Actual)
Primary Completion Date
February 11, 2016 (Actual)
Study Completion Date
November 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myositis, Polymyositis, Dermatomyositis, Myositis, Inclusion Body
Keywords
Myositis, Magnetic Resonance Imaging, Muscle biopsy, Sensitivity and Specificity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI-oriented muscle biopsy
Arm Type
Other
Arm Description
Muscle sample will be done following the usual care.
Intervention Type
Procedure
Intervention Name(s)
MRI-oriented muscle biopsy
Intervention Description
Orientation of muscle biopsy according to the MRI results
Primary Outcome Measure Information:
Title
Evaluation of T1 and STIR (Short Tau Inversion Recovery) sequences of muscle MRI.
Description
Description : diagnostic accuracy of muscle MRI (in terms of sensitivity, specificity, predictive positive value and predictive negative value) for the diagnostic of inflammatory myopathy.
Time Frame
between Day 0 and 24 months
Title
Presence of IIM diagnosed by muscle biopsy
Description
Presence of IIM according to ENMC histological criteria
Time Frame
between Day 0 and 24 months
Secondary Outcome Measure Information:
Title
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation
Description
Evaluation of reproductibility intra- versus inter-observers for muscle biopsy interpretation according to ENMC (European Neuromuscular Centre) classification (calculation of Kappa coefficients).
Time Frame
every 3 months (up to 24 months)
Title
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation
Description
Evaluation of reproductibility intra- versus inter-observers for muscle MRI interpretation (calculation of Kappa coefficients).
Time Frame
every 3 months (up to 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves ALLENBACH, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies
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