Clinical trial NCT01702870: Diagnostic Accuracy of MR in Myositis
Official title: Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myositis
Muscular Disorders, Atrophic
Keywords: Magnetic resonance imaging
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: West Midlands Comprehensive Local Research Network
name: University Hospitals Coventry and Warwickshire NHS Trust
name: Northern Care Alliance NHS Foundation Trust
name: The Royal College of Radiologists
First posted: 2012-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MR signal (T1w, T2w and STIR sequences) in muscle.
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)
timeFrame: 2 years
measure: Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity
timeFrame: 2 years
Other outcomes:
measure: Sensitivity and specificity of MR against the gold standard of clinical criteria
timeFrame: 2 years
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Lancashire
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital NHS Trust
state: Warwickshire
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
state: West Midlands
Study officials:
affiliation: Professor of Imaging (Radiology), University of Warwick
name: Charles Hutchinson, MD FRCR
role: STUDY_CHAIR
affiliation: Clinical Research fellow in Radiology, University of Warwick
name: Terence Jones, MBChB FRCR
role: PRINCIPAL_INVESTIGATOR
References: