Diagnostic Accuracy of MR in Myositis

Myositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01702870
• Other study ID #: UoW-Myositis01
• Status: Not yet recruiting
• Phase: N/A
• First received: October 4, 2012
• Last updated: October 16, 2012
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: October 2012
• Source: University of Warwick
• Contact: Terence Jones, MBChB FRCR
• Email: t.a.jones[@]warwick.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscular Diseases
• Muscular Disorders, Atrophic
• Myositis

Intervention

Procedure:
• Magnetic Resonance Imaging

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry and Warwickshire NHS Trust	Coventry	West Midlands
United Kingdom	George Eliot Hospital NHS Trust	Nuneaton	Warwickshire
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Lancashire

Sponsors (5)

Lead Sponsor	Collaborator
University of Warwick	Salford Royal NHS Foundation Trust, The Royal College of Radiologists, University Hospitals Coventry and Warwickshire NHS Trust, West Midlands Comprehensive Local Research Network

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	MR signal (T1w, T2w and STIR sequences) in muscle.	The correlation between MR signal and the clinical criteria will be measured	2 years	No
Secondary	Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)		2 years	No
Secondary	Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity		2 years	No