Diagnostic Accuracy of MR in Myositis

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

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

Study Overview

• Status: Unknown
• Conditions: Muscular Disorders, Atrophic; Myositis
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Salford, Lancashire, United Kingdom, M6 8HD
      • Salford Royal NHS Foundation Trust
  • Warwickshire
    • Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
      • George Eliot Hospital NHS Trust
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospitals Coventry and Warwickshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group will be patients attendeing rheumatology outpoatient clinics with a suspected diagnosis of myopathy based on clinical criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected myositis; Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging	Procedure: Magnetic Resonance Imaging; Other Names: Magnetic Resonance Imaging of the thighs
Controls; Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle	Procedure: Magnetic Resonance Imaging; Other Names: Magnetic Resonance Imaging of the thighs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Warwick
• Collaborators: Northern Care Alliance NHS Foundation Trust; University Hospitals Coventry and Warwickshire NHS Trust; West Midlands Comprehensive Local Research Network; The Royal College of Radiologists
• Investigators: Study Chair: Charles Hutchinson, MD FRCR, Professor of Imaging (Radiology), University of Warwick; Principal Investigator: Terence Jones, MBChB FRCR, Clinical Research fellow in Radiology, University of Warwick

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Study Completion (ANTICIPATED): November 1, 2014

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (ESTIMATE): October 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2012
• Last Update Submitted That Met QC Criteria: October 16, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases; Myositis; Muscular Disorders, Atrophic
• Other Study ID Numbers: UoW-Myositis01