Diagnostic Accuracy of MR in Myositis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by University of Warwick
Sponsor:
Collaborators:
West Midlands Comprehensive Local Research Network
University Hospitals Coventry and Warwickshire NHS Trust
Salford Royal NHS Foundation Trust
The Royal College of Radiologists
Information provided by (Responsible Party):
Dr. Terence Jones, University of Warwick
ClinicalTrials.gov Identifier:
NCT01702870
First received: October 4, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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 Intervention
Myositis
Muscular Disorders, Atrophic
Procedure: Magnetic Resonance Imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy

Resource links provided by NLM:


Further study details as provided by University of Warwick:

Primary Outcome Measures:
  • MR signal (T1w, T2w and STIR sequences) in muscle. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The correlation between MR signal and the clinical criteria will be measured


Secondary Outcome Measures:
  • Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Sensitivity and specificity of MR against the gold standard of clinical criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique


Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702870

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

Locations
United Kingdom
Salford Royal NHS Foundation Trust Not yet recruiting
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 Not yet recruiting
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 Not yet recruiting
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
Salford Royal NHS Foundation Trust
The Royal College of Radiologists
Investigators
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

No publications provided

Responsible Party: Dr. Terence Jones, Clinical Research Fellow in Radiology, University of Warwick
ClinicalTrials.gov Identifier: NCT01702870     History of Changes
Other Study ID Numbers: UoW-Myositis01
Study First Received: October 4, 2012
Last Updated: October 16, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Warwick:
Magnetic resonance imaging

Additional relevant MeSH terms:
Muscular Diseases
Myositis
Atrophy
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014