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Diagnostic Accuracy of MR in Myositis

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ClinicalTrials.gov Identifier: NCT01702870
Recruitment Status : Unknown
Verified October 2012 by Dr. Terence Jones, University of Warwick.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2012
Last Update Posted : October 18, 2012
Sponsor:
Collaborators:
West Midlands Comprehensive Local Research Network
University Hospitals Coventry and Warwickshire NHS Trust
Northern Care Alliance NHS Foundation Trust
The Royal College of Radiologists
Information provided by (Responsible Party):
Dr. Terence Jones, University of Warwick

Study Description
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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.

Condition or disease Intervention/treatment
Myositis Muscular Disorders, Atrophic Procedure: Magnetic Resonance Imaging

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
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Study Type : Observational
Estimated Enrollment : 70 participants
Time Perspective: Prospective
Official Title: Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy
Study Start Date : November 2012
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Suspected myositis
Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging
 Procedure: Magnetic Resonance Imaging
Other Name: Magnetic Resonance Imaging of the thighs
Controls
Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle
 Procedure: Magnetic Resonance Imaging
Other Name: Magnetic Resonance Imaging of the thighs


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

Other Outcome Measures:
  1. Sensitivity and specificity of MR against the gold standard of clinical criteria [ Time Frame: 2 years ]
    The MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702870


Contacts
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Contact: Terence Jones, MBChB FRCR t.a.jones@warwick.ac.uk

Locations
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United Kingdom
Salford Royal NHS Foundation Trust
Salford, Lancashire, United Kingdom, M6 8HD
Contact: Hector Chinoy, PhD MRCP       hector.chinoy@manchester.ac.uk   
Principal Investigator: Hector Chinoy, PhD MRCP         
George Eliot Hospital NHS Trust
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
Contact: Terence Jones, MBChB FRCR       t.a.jones@warwick.ac.uk   
Sub-Investigator: Alec Price-Forbes, MBChB MRCP         
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX
Contact: Terence Jones, MBChB FRCR       t.a.jones@warwick.ac.uk   
Principal Investigator: Terence Jones, MBChB FRCR         
Sponsors and Collaborators
University of Warwick
West Midlands Comprehensive Local Research Network
University Hospitals Coventry and Warwickshire NHS Trust
Northern Care Alliance NHS Foundation Trust
The Royal College of Radiologists
Investigators
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Study Chair: Charles Hutchinson, MD FRCR Professor of Imaging (Radiology), University of Warwick
Principal Investigator: Terence Jones, MBChB FRCR Clinical Research fellow in Radiology, University of Warwick
More Information
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Responsible Party: Dr. Terence Jones, Clinical Research Fellow in Radiology, University of Warwick
ClinicalTrials.gov Identifier: NCT01702870    
Other Study ID Numbers: UoW-Myositis01
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012
Keywords provided by Dr. Terence Jones, University of Warwick:
Magnetic resonance imaging
Additional relevant MeSH terms:
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Myositis
Muscular Diseases
Muscular Disorders, Atrophic
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases