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| Name | Class |
|---|---|
| West Midlands Comprehensive Local Research Network | UNKNOWN |
| University Hospitals Coventry and Warwickshire NHS Trust | OTHER |
| Northern Care Alliance NHS Foundation Trust | OTHER |
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A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected myositis | Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging |
| |
| Controls | Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| MR signal (T1w, T2w and STIR sequences) in muscle. | The correlation between MR signal and the clinical criteria will be measured | 2 years |
| Measure | Description | Time 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 specificity | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of MR against the gold standard of clinical criteria | The MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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The study group will be patients attendeing rheumatology outpoatient clinics with a suspected diagnosis of myopathy based on clinical criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Terence Jones, MBChB FRCR | Contact | t.a.jones@warwick.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Charles Hutchinson, MD FRCR | Professor of Imaging (Radiology), University of Warwick | Study Chair |
| Terence Jones, MBChB FRCR | Clinical Research fellow in Radiology, University of Warwick | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salford Royal NHS Foundation Trust | Salford | Lancashire | M6 8HD | United Kingdom |
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| ID | Term |
|---|---|
| D009220 | Myositis |
| D020966 | Muscular Disorders, Atrophic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| The Royal College of Radiologists |
| UNKNOWN |
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| George Eliot Hospital NHS Trust | Nuneaton | Warwickshire | CV10 7DJ | United Kingdom |
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| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | West Midlands | CV2 2DX | United Kingdom |
|