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CompletedNCT01432613DARWIMUpdated Mar 31, 2026

Diagnostic Accuracy of Whole Body Magnetic Resonance Imaging in Inflammatory Myopathies

An interventional study of MRI-oriented muscle biopsy in Myositis, Polymyositis and Dermatomyositis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2010, registered Aug 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Myositis
  • Polymyositis
  • Dermatomyositis
  • Myositis, Inclusion Body

Keywords

  • Myositis
  • Magnetic Resonance Imaging
  • Muscle biopsy
  • Sensitivity and Specificity
03

In context

Myositis

215 studies on the registry are indexed under Myositis; 100 are open to participants now.

This study's enrollment of 139 is above the median of 30 across 141 interventional studies indexed under Myositis.

Browse Myositis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant female
  • Proximal motive neuropathy
  • Refusing participation
  • Patient under 18 years old
  • Adult patient under legal protection
  • Patient with 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
139 participants (actual)

Study arms

  • Other
    MRI-oriented muscle biopsy

    Muscle sample will be done following the usual care.

    Procedure: MRI-oriented muscle biopsy

Interventions

  • ProcedureMRI-oriented muscle biopsy

    Orientation of muscle biopsy according to the MRI results

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: between Day 0 and 24 months

  2. Presence of IIM diagnosed by muscle biopsy

    Presence of IIM according to ENMC histological criteria

    Time frame: between Day 0 and 24 months

Secondary outcomes

  1. 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).

    Time frame: every 3 months (up to 24 months)

  2. 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).

    Time frame: every 3 months (up to 24 months)

07

Study locations

1 site
  • CHU Amiens Nord
    Amiens, 80054, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2010 to primary completion in Feb 2016, 61 months.

Of 19 interventional studies with no phase under Myositis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 61 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2011
First posted
Sep 13, 2011
StartActual
Dec 22, 2010
Primary completionActual
Feb 11, 2016
CompletionActual
Nov 26, 2016
Last update
Mar 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01432613
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Sep 13, 2011
Start date
Dec 22, 2010
Primary completion
Feb 11, 2016
Completion
Nov 26, 2016
Last update
Mar 31, 2026

Study contacts

Yves ALLENBACH, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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