Clinical Trial: Diagnostic Accuracy of MR in Myositis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary:

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.


Sponsor: University of Warwick

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria) [ Time Frame: 2 years ]
  • Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: University of Warwick

Dates:
Date Received: October 4, 2012
Date Started: November 2012
Date Completion: November 2014
Last Updated: October 16, 2012
Last Verified: October 2012