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Diagnostic Accuracy of MR in Myositis

U

University of Warwick

Status

Unknown

Conditions

Myositis
Muscular Disorders, Atrophic

Treatments

Procedure: Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT01702870
UoW-Myositis01

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

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

Trial contacts and locations

3

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Central trial contact

Terence Jones, MBChB FRCR

Data sourced from clinicaltrials.gov

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