Diagnostic Accuracy of MR in Myositis
Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy
1 other identifier
observational
70
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2012
CompletedFirst Posted
Study publicly available on registry
October 10, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedOctober 18, 2012
October 1, 2012
October 4, 2012
October 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MR signal (T1w, T2w and STIR sequences) in muscle.
The correlation between MR signal and the clinical criteria will be measured
2 years
Secondary Outcomes (2)
Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)
2 years
Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity
2 years
Other Outcomes (1)
Sensitivity and specificity of MR against the gold standard of clinical criteria
2 years
Study Arms (2)
Suspected myositis
Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging
Controls
Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle
Interventions
Eligibility Criteria
The study group will be patients attendeing rheumatology outpoatient clinics with a suspected diagnosis of myopathy based on clinical criteria
You may qualify if:
- Any adult patient referred for an MR scan with a suspected clinical diagnosis of myopathy.
You may not qualify if:
- Patient unable or unwilling to have an MR scan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Warwicklead
- West Midlands Comprehensive Local Research Networkcollaborator
- University Hospitals Coventry and Warwickshire NHS Trustcollaborator
- Northern Care Alliance NHS Foundation Trustcollaborator
- The Royal College of Radiologistscollaborator
Study Sites (3)
Salford Royal NHS Foundation Trust
Salford, Lancashire, M6 8HD, United Kingdom
George Eliot Hospital NHS Trust
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Fellow in Radiology
Study Record Dates
First Submitted
October 4, 2012
First Posted
October 10, 2012
Study Start
November 1, 2012
Study Completion
November 1, 2014
Last Updated
October 18, 2012
Record last verified: 2012-10