Diagnostic Accuracy of MR in Myositis

October 16, 2012 updated by: Dr. Terence Jones, University of Warwick

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

A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Lancashire
      • Salford, Lancashire, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Hector Chinoy, PhD MRCP
    • Warwickshire
      • Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
        • George Eliot Hospital NHS Trust
        • Contact:
        • Sub-Investigator:
          • Alec Price-Forbes, MBChB MRCP
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust
        • Contact:
        • Principal Investigator:
          • Terence Jones, MBChB FRCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Magnetic Resonance Imaging of the thighs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warwick

Collaborators

Northern Care Alliance NHS Foundation Trust
University Hospitals Coventry and Warwickshire NHS Trust
West Midlands Comprehensive Local Research Network
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (ESTIMATE)

October 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UoW-Myositis01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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