Diagnostic Accuracy of MR in Myositis

• Conditions: Myositis; Muscular Disorders, Atrophic
• Interventions: Procedure: Magnetic Resonance Imaging

• Registration Number: NCT01702870
• Lead Sponsor: University of Warwick

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.

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-10
• Last Update Submitted: 2012-10-16
• Last Update Posted: 2012-10-18
• Study Start: 2012-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 exclusion criteria will apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected myositis	Magnetic Resonance Imaging	Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging
Controls	Magnetic Resonance Imaging	Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle

Primary Outcome Measures

Name	Time	Method
MR signal (T1w, T2w and STIR sequences) in muscle.	2 years	The correlation between MR signal and the clinical criteria will be measured

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

George Eliot Hospital NHS Trust; 🇬🇧 Nuneaton, Warwickshire, United Kingdom

Salford Royal NHS Foundation Trust; 🇬🇧 Salford, Lancashire, United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust; 🇬🇧 Coventry, West Midlands, United Kingdom