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Clinical Trials/NCT01702870
NCT01702870UnknownNot Applicable

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

University of Warwick3 sites in 1 country70 target enrollmentStarted: November 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
70
Locations
3
Primary Endpoint
MR signal (T1w, T2w and STIR sequences) in muscle.

Study Overview

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 Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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 exclusion criteria will apply.

Outcomes

Primary Outcomes

MR signal (T1w, T2w and STIR sequences) in muscle.

Time Frame: 2 years

The correlation between MR signal and the clinical criteria will be measured

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Terence Jones

Clinical Research Fellow in Radiology

University of Warwick

Study Sites (3)

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