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Diagnostic Accuracy of MR in Myositis

NCT ID: NCT01702870

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Myositis Muscular Disorders, Atrophic

Keywords

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Magnetic resonance imaging

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected myositis

Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Controls

Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Interventions

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Magnetic Resonance Imaging

Intervention Type PROCEDURE

Other Intervention Names

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Magnetic Resonance Imaging of the thighs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West Midlands Comprehensive Local Research Network

UNKNOWN

Sponsor Role collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role collaborator

Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role collaborator

The Royal College of Radiologists

UNKNOWN

Sponsor Role collaborator

University of Warwick

OTHER

Sponsor Role lead

Responsible Party

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Dr. Terence Jones

Clinical Research Fellow in Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Hutchinson, MD FRCR

Role: STUDY_CHAIR

Professor of Imaging (Radiology), University of Warwick

Terence Jones, MBChB FRCR

Role: PRINCIPAL_INVESTIGATOR

Clinical Research fellow in Radiology, University of Warwick

Locations

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Salford Royal NHS Foundation Trust

Salford, Lancashire, United Kingdom

Site Status

George Eliot Hospital NHS Trust

Nuneaton, Warwickshire, United Kingdom

Site Status

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Terence Jones, MBChB FRCR

Role: CONTACT

Email: [email protected]

Facility Contacts

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Hector Chinoy, PhD MRCP

Role: primary

Terence Jones, MBChB FRCR

Role: primary

Terence Jones, MBChB FRCR

Role: primary

Other Identifiers

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UoW-Myositis01

Identifier Type: -

Identifier Source: org_study_id