<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702870</url>
  </required_header>
  <id_info>
    <org_study_id>UoW-Myositis01</org_study_id>
    <nct_id>NCT01702870</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of MR in Myositis</brief_title>
  <official_title>Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Midlands Comprehensive Local Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northern Care Alliance NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal College of Radiologists</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Warwick</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective observational study to determine the effectiveness of magnetic resonance (MR)&#xD;
      imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic inflammatory myopathies are a heterogeneous group of conditions characterised by&#xD;
      skeletal muscle inflammation leading to proximal muscle weakness, often with tenderness, and&#xD;
      occasionally dermatological manifestations. Diagnosis is clinical and is based on the Bohan&#xD;
      and Peter criteria which comprises clinical examination, serological markers,&#xD;
      electromyography (EMG) and muscle biopsy. This has relatively poor sensitivity and&#xD;
      specificity. Muscle biopsy in particular has a false negative rate of 10-15% and is invasive.&#xD;
      Clinical criteria also lack the discriminatory power to differentiate between recurrent (or&#xD;
      breakthrough) myopathy and myopathy secondary to treatment with corticosteroid.&#xD;
&#xD;
      Magnetic resonance (MR) imaging has the advantage of being non-invasive, and is able to&#xD;
      discriminate between different tissues, and to identify areas of inflammation. The aim of&#xD;
      this study is to assess the effectiveness of MR sequences in the diagnosis of myopathy,&#xD;
      monitoring of treatment response, and in differentiating between breakthrough myopathy and&#xD;
      steroid-induced myopathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MR signal (T1w, T2w and STIR sequences) in muscle.</measure>
    <time_frame>2 years</time_frame>
    <description>The correlation between MR signal and the clinical criteria will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Sensitivity and specificity of MR against the gold standard of clinical criteria</measure>
    <time_frame>2 years</time_frame>
    <description>The MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Myositis</condition>
  <condition>Muscular Disorders, Atrophic</condition>
  <arm_group>
    <arm_group_label>Suspected myositis</arm_group_label>
    <description>Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Suspected myositis</arm_group_label>
    <other_name>Magnetic Resonance Imaging of the thighs</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study group will be patients attendeing rheumatology outpoatient clinics with a&#xD;
        suspected diagnosis of myopathy based on clinical criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult patient referred for an MR scan with a suspected clinical diagnosis of&#xD;
             myopathy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable or unwilling to have an MR scan.&#xD;
&#xD;
          -  Standard MR exclusion criteria will apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Hutchinson, MD FRCR</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Imaging (Radiology), University of Warwick</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Terence Jones, MBChB FRCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research fellow in Radiology, University of Warwick</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Terence Jones, MBChB FRCR</last_name>
    <email>t.a.jones@warwick.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Salford Royal NHS Foundation Trust</name>
      <address>
        <city>Salford</city>
        <state>Lancashire</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Hector Chinoy, PhD MRCP</last_name>
      <email>hector.chinoy@manchester.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Hector Chinoy, PhD MRCP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>George Eliot Hospital NHS Trust</name>
      <address>
        <city>Nuneaton</city>
        <state>Warwickshire</state>
        <zip>CV10 7DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Terence Jones, MBChB FRCR</last_name>
      <email>t.a.jones@warwick.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Alec Price-Forbes, MBChB MRCP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Coventry and Warwickshire NHS Trust</name>
      <address>
        <city>Coventry</city>
        <state>West Midlands</state>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Terence Jones, MBChB FRCR</last_name>
      <email>t.a.jones@warwick.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Terence Jones, MBChB FRCR</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Warwick</investigator_affiliation>
    <investigator_full_name>Dr. Terence Jones</investigator_full_name>
    <investigator_title>Clinical Research Fellow in Radiology</investigator_title>
  </responsible_party>
  <keyword>Magnetic resonance imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Muscular Disorders, Atrophic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702870
org study id: UoW-Myositis01
nct id: NCT01702870
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A prospective observational study to determine the effectiveness of magnetic resonance (MR)
      imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.
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.
time perspective: Prospective
measure: MR signal (T1w, T2w and STIR sequences) in muscle.
time frame: 2 years
description: The correlation between MR signal and the clinical criteria will be measured
measure: Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)
time frame: 2 years
measure: Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity
time frame: 2 years
measure: Sensitivity and specificity of MR against the gold standard of clinical criteria
time frame: 2 years
description: The MR signal will be compared against the Bohan and Peters criteria (the current gold standard) to determine sensitivity and specificity of the technique
arm group label: Suspected myositis
description: Participants with suspected myositis based on clinical criteria (Bohan and Peters criteria) referred for Magnetic resonance imaging
arm group label: Controls
description: Normal volunteers without myositis, who will undergo MR imaging to establish normal ranges of MR signal in health muscle
intervention type: Procedure
intervention name: Magnetic Resonance Imaging
arm group label: Controls
arm group label: Suspected myositis
other name: Magnetic Resonance Imaging of the thighs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Hutchinson, MD FRCR
role: Study Chair
affiliation: Professor of Imaging (Radiology), University of Warwick
last name: Terence Jones, MBChB FRCR
role: Principal Investigator
affiliation: Clinical Research fellow in Radiology, University of Warwick
last name: Terence Jones, MBChB FRCR
email: t.a.jones@warwick.ac.uk
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Warwick
investigator full name: Dr. Terence Jones
investigator title: Clinical Research Fellow in Radiology
mesh term: Myositis
mesh term: Muscular Diseases
mesh term: Muscular Disorders, Atrophic