MyositisNCT01702870
Diagnostic Accuracy of MR in Myositis
An observational study of Myositis and Muscular Disorders, Atrophic, run by University of Warwick at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myositis, Muscular Disorders, Atrophic
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group will be patients attendeing rheumatology outpoatient clinics with a suspected diagnosis of myopathy based on clinical criteria
Who may be able to join
- Any adult patient referred for an MR scan with a suspected clinical diagnosis of myopathy.
Who cannot join
- Patient unable or unwilling to have an MR scan.
- Standard MR exclusion criteria will apply.
Trial locations and contacts
3 sites in 1 country.
Terence Jones, MBChB FRCR contact
United Kingdom3 sites
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
Terence Jones, MBChB FRCR, t.a.jones@warwick.ac.uk
Terence Jones, MBChB FRCR
George Eliot Hospital NHS Trust
Nuneaton, Warwickshire, CV10 7DJ
Terence Jones, MBChB FRCR, t.a.jones@warwick.ac.uk
Alec Price-Forbes, MBChB MRCP
Salford Royal NHS Foundation Trust
Salford, Lancashire, M6 8HD
Hector Chinoy, PhD MRCP, hector.chinoy@manchester.ac.uk
Hector Chinoy, PhD MRCP
About this study
Official title: 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.
Read the 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.
- Conditions
- Myositis, Muscular Disorders, Atrophic
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Magnetic resonance imaging
- Medical subject headings
- Myositis, Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging of the thighs
| Study group | Role | What they receive |
|---|---|---|
| Suspected myositis | Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging Receives: Procedure: Magnetic Resonance Imaging | |
| Controls | Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle Receives: Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR signal (T1w, T2w and STIR sequences) in muscle.
The correlation between MR signal and the clinical criteria will be measured
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)
Measured: 2 years
Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2012
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr. Terence Jones, University of Warwick
- Investigators
- Charles Hutchinson, MD FRCR, Study chair, Professor of Imaging (Radiology), University of WarwickTerence Jones, MBChB FRCR, Principal investigator, Clinical Research fellow in Radiology, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702870
- Sponsor's protocol ID
- UoW-Myositis01
- Status last verified
- Oct 2012
- First submitted
- 4 Oct 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy
- ClinicalTrials.gov ID
- NCT01702870
- Acronym / sponsor ID
- UoW-Myositis01
- Conditions
- Myositis, Muscular Disorders, Atrophic
- Keywords
- Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- 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
- Study start
- Nov 2012
- Study completion
- Nov 2014 (estimated)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected myositis | – | Procedure: Magnetic Resonance ImagingParticipants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging |
| Controls | – | Procedure: Magnetic Resonance ImagingNormal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will be patients attendeing rheumatology outpoatient clinics with a suspected diagnosis of myopathy based on clinical criteria
Key inclusion criteria (1 listed)
- Any adult patient referred for an MR scan with a suspected clinical diagnosis of myopathy.
Key exclusion criteria (2 listed)
- Patient unable or unwilling to have an MR scan.
- Standard MR exclusion criteria will apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging of the thighs | Procedure or surgery | Controls, Suspected myositis |
Primary outcome
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 secondary outcomes
Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)
Time frame: 2 years
Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence Jones, MBChB FRCR contact
Charles Hutchinson, MD FRCR study chair
Professor of Imaging (Radiology), University of Warwick
Terence Jones, MBChB FRCR principal investigator
Clinical Research fellow in Radiology, University of Warwick
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myositis and Muscular Disorders, Atrophic, run by University of Warwick at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terence Jones, MBChB FRCR (t.a.jones@warwick.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR signal (T1w, T2w and STIR sequences) in muscle. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.