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Diagnostic Accuracy of MR in Myositis

Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01702870
Enrollment
70
Registered
2012-10-10
Start date
2012-11-30
Completion date
2014-11-30
Last updated
2012-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscular Disorders, Atrophic, Myositis

Keywords

Magnetic resonance imaging

Brief summary

A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.

Detailed description

Idiopathic inflammatory myopathies are a heterogeneous group of conditions characterised by skeletal muscle inflammation leading to proximal muscle weakness, often with tenderness, and occasionally dermatological manifestations. Diagnosis is clinical and is based on the Bohan and Peter criteria which comprises clinical examination, serological markers, electromyography (EMG) and muscle biopsy. This has relatively poor sensitivity and specificity. Muscle biopsy in particular has a false negative rate of 10-15% and is invasive. Clinical criteria also lack the discriminatory power to differentiate between recurrent (or breakthrough) myopathy and myopathy secondary to treatment with corticosteroid. Magnetic resonance (MR) imaging has the advantage of being non-invasive, and is able to discriminate between different tissues, and to identify areas of inflammation. The aim of this study is to assess the effectiveness of MR sequences in the diagnosis of myopathy, monitoring of treatment response, and in differentiating between breakthrough myopathy and steroid-induced myopathy.

Interventions

PROCEDUREMagnetic Resonance Imaging

Sponsors

West Midlands Comprehensive Local Research Network
CollaboratorUNKNOWN
University Hospitals Coventry and Warwickshire NHS Trust
CollaboratorOTHER
Northern Care Alliance NHS Foundation Trust
CollaboratorOTHER
The Royal College of Radiologists
CollaboratorUNKNOWN
University of Warwick
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Any adult patient referred for an MR scan with a suspected clinical diagnosis of myopathy.

Exclusion criteria

* Patient unable or unwilling to have an MR scan. * Standard MR

Design outcomes

Primary

MeasureTime frameDescription
MR signal (T1w, T2w and STIR sequences) in muscle.2 yearsThe correlation between MR signal and the clinical criteria will be measured

Secondary

MeasureTime frame
Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)2 years
Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity2 years

Other

MeasureTime frameDescription
Sensitivity and specificity of MR against the gold standard of clinical criteria2 yearsThe MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique

Countries

United Kingdom

Contacts

Primary ContactTerence Jones, MBChB FRCR
t.a.jones@warwick.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026