<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/NCT03832556</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02783-52</org_study_id>
    <nct_id>NCT03832556</nct_id>
  </id_info>
  <brief_title>Comparison Between CT and MRI in Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis</brief_title>
  <acronym>MON-IRM</acronym>
  <official_title>Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The principal objective of the study is to compare between CT and MRI diagnostic performance&#xD;
      (sensibility and specificity) in the preoperative assessment of neurogenic&#xD;
      para-osteo-arthritis.&#xD;
&#xD;
      The second objectives of the study are:&#xD;
&#xD;
        -  besides the diagnostic performance (sensibility and specificity), to evaluate the&#xD;
           imaging par MRI in visual and descriptive manner heterotopic ossification and connection&#xD;
           with vascular and nervous structures.&#xD;
&#xD;
        -  to study the concordance (two by two) of results of preoperative obtained by MRI and by&#xD;
           CT and operative reports.&#xD;
&#xD;
        -  to study the characteristics of patients with discordant findings (two by two) by MRI,&#xD;
           CT scan and operative report.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study on diagnostic performance, non randomized, versus Gold standard (a&#xD;
      prospective multicentric cohort).&#xD;
&#xD;
      All eligible patients will be proposed consecutively to participate to the study, to undergo&#xD;
      preoperative CT scan and MRI examination as usual procedure. The only additional action in&#xD;
      this study will be a neurography sequence of type fluorescence subtraction imaging (FSI)&#xD;
      during MRI, permitting to obtain more details in visualization of nerve structure and their&#xD;
      relations of the ossifications.&#xD;
&#xD;
      The enrollment visit will performed by neuro-orthopaedic surgeon during preoperative&#xD;
      consultation.&#xD;
&#xD;
      The follow-up visit will be an usual post-operative visit, non-specific for the study.&#xD;
&#xD;
      The duration for each participant will compound 1 month (the duration between preoperative&#xD;
      imaging and surgical resection) added by up to two months of post-operative follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Actual">February 7, 2023</completion_date>
  <primary_completion_date type="Actual">February 7, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of topography of heterotopic ossification.&#xD;
On each CT and MRI exam, analysis of accurate topography of heterotopic ossifications relative to the bones, the number of fragments, their relationships with the articular capsule, their mineralization, and the mineralization of the underlying bone.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis and comparison of reporting arterial and venous anatomy</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting arterial and venous anatomy.&#xD;
On each CT and MRI exam, analysis of vascular (arterial and veinous) relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the vessels permeability or occlusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis and comparison of reporting nervous structures</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting nervous structures.&#xD;
On each CT and MRI exam, analysis of nervous structures relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the the existence of suffering nerve or denervation signs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performances of MRI for diagnosis of arterial-venous</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Performances of MRI for diagnosis of arterial-venous relation (gutter, stenosis, thrombosis or vascular occlusion, collateral circulation...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performances of MRI for diagnosis of nervous structures (nerve's location, nerve signal anomalies, signs of suffering and denervation...)</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of incidence of adverse event during surgical operation</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>The rate of incidence of adverse event during surgical procedure will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance correlation coefficient</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Concordance correlation coefficient two by two (Gwet concordance coefficient for binary qualitative variables; and W of Kendal concordance coefficient for ordinal qualitative variables or quantitative variables) between results of preoperative MRI and CT and operative report describing arterial-venous relation, and nervous structures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristic of patients with discordant results</measure>
    <time_frame>through study completion, an average of 2 year</time_frame>
    <description>Identify all discordances between CT or MRI and the surgery findings, about topography of heterotopic ossification, vascular relations and nervous structures relations.&#xD;
Analysis of characteristics of patients with discordant results between preoperative MRI resluts or preoperative CT results relative to the operative report.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Neurogenic Myositis Ossificans</condition>
  <condition>Neurogenic Para-osteo-arthritis</condition>
  <arm_group>
    <arm_group_label>Preoperative evaluation: CT + MRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperative evaluation by 2 examinations: CT scan and MRI.&#xD;
CT scan with biphasic injection of contrast product;&#xD;
MRI with injection of contrast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT scan</intervention_name>
    <description>CT scan with biphasic injection of contrast product</description>
    <arm_group_label>Preoperative evaluation: CT + MRI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI examination</intervention_name>
    <description>MRI with injection of contrast</description>
    <arm_group_label>Preoperative evaluation: CT + MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient with neurogenic para-osteo-arthropathy resulted by prior central nervous&#xD;
             system, cerebral or medullar damage&#xD;
&#xD;
          -  Deformation with limitation of articular amplitude which could result limitation in&#xD;
             rehabilitation care&#xD;
&#xD;
          -  An indication of partial or total surgical excision of heterotopic ossification&#xD;
&#xD;
          -  Indication of pre-operative assessment by CT scan and MRI, with contrast product&#xD;
             injection&#xD;
&#xD;
          -  Signed consent of patient obtained after clear and relevant informations given by&#xD;
             physician&#xD;
&#xD;
          -  Patient covered by social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to an MRI examination: cardiac stimulator, metallic intraocular&#xD;
             foreign bodies...&#xD;
&#xD;
          -  Contraindications to CT scan&#xD;
&#xD;
          -  Contraindications to contrast injection product, such as iodinated or gadolinium-based&#xD;
             contrast media&#xD;
&#xD;
          -  Impractical venous access&#xD;
&#xD;
          -  Severe deformation resulting impossibility to positioning for MRI examination or CT&#xD;
             scan&#xD;
&#xD;
          -  Patient can not give consent&#xD;
&#xD;
          -  Participation to another interventional study&#xD;
&#xD;
          -  Patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Carlier, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raphaël AMAR, Resident</last_name>
    <role>Study Director</role>
    <affiliation>Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service d'Imagerie médicale, Hôpital Raymond Poincaré</name>
      <address>
        <city>Garches</city>
        <state>Hauts-de-Seine</state>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neurogenic myositis ossificans</keyword>
  <keyword>para-osteo-arthropathy</keyword>
  <keyword>preoperative evaluation</keyword>
  <keyword>CT scan</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Myositis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Myositis Ossificans</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03832556
org study id: 2018-A02783-52
nct id: NCT03832556
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The principal objective of the study is to compare between CT and MRI diagnostic performance
      (sensibility and specificity) in the preoperative assessment of neurogenic
      para-osteo-arthritis.

      The second objectives of the study are:

        -  besides the diagnostic performance (sensibility and specificity), to evaluate the
           imaging par MRI in visual and descriptive manner heterotopic ossification and connection
           with vascular and nervous structures.

        -  to study the concordance (two by two) of results of preoperative obtained by MRI and by
           CT and operative reports.

        -  to study the characteristics of patients with discordant findings (two by two) by MRI,
           CT scan and operative report.
This is a study on diagnostic performance, non randomized, versus Gold standard (a
      prospective multicentric cohort).

      All eligible patients will be proposed consecutively to participate to the study, to undergo
      preoperative CT scan and MRI examination as usual procedure. The only additional action in
      this study will be a neurography sequence of type fluorescence subtraction imaging (FSI)
      during MRI, permitting to obtain more details in visualization of nerve structure and their
      relations of the ossifications.

      The enrollment visit will performed by neuro-orthopaedic surgeon during preoperative
      consultation.

      The follow-up visit will be an usual post-operative visit, non-specific for the study.

      The duration for each participant will compound 1 month (the duration between preoperative
      imaging and surgical resection) added by up to two months of post-operative follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Analysis and comparison of accurate topography of heterotopic ossification on the CT and the MRI
time frame: through study completion, an average of 2 year
description: Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of topography of heterotopic ossification.
On each CT and MRI exam, analysis of accurate topography of heterotopic ossifications relative to the bones, the number of fragments, their relationships with the articular capsule, their mineralization, and the mineralization of the underlying bone.
measure: Analysis and comparison of reporting arterial and venous anatomy
time frame: through study completion, an average of 2 year
description: Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting arterial and venous anatomy.
On each CT and MRI exam, analysis of vascular (arterial and veinous) relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the vessels permeability or occlusion.
measure: Analysis and comparison of reporting nervous structures
time frame: through study completion, an average of 2 year
description: Comparison of preoperative diagnostic performances of CT scan and MRI, based on analysis of reporting nervous structures.
On each CT and MRI exam, analysis of nervous structures relations with the heterotopic ossifications, in the case of contact specify the existence of a gutter or a tunnel, and the the existence of suffering nerve or denervation signs.
measure: Performances of MRI for diagnosis of arterial-venous
time frame: through study completion, an average of 2 year
description: Performances of MRI for diagnosis of arterial-venous relation (gutter, stenosis, thrombosis or vascular occlusion, collateral circulation...)
measure: Performances of MRI for diagnosis of nervous structures (nerve's location, nerve signal anomalies, signs of suffering and denervation...)
time frame: through study completion, an average of 2 year
measure: Rate of incidence of adverse event during surgical operation
time frame: through study completion, an average of 2 year
description: The rate of incidence of adverse event during surgical procedure will be calculated.
measure: Concordance correlation coefficient
time frame: through study completion, an average of 2 year
description: Concordance correlation coefficient two by two (Gwet concordance coefficient for binary qualitative variables; and W of Kendal concordance coefficient for ordinal qualitative variables or quantitative variables) between results of preoperative MRI and CT and operative report describing arterial-venous relation, and nervous structures.
measure: Characteristic of patients with discordant results
time frame: through study completion, an average of 2 year
description: Identify all discordances between CT or MRI and the surgery findings, about topography of heterotopic ossification, vascular relations and nervous structures relations.
Analysis of characteristics of patients with discordant results between preoperative MRI resluts or preoperative CT results relative to the operative report.
arm group label: Preoperative evaluation: CT + MRI
arm group type: Experimental
description: Preoperative evaluation by 2 examinations: CT scan and MRI.
CT scan with biphasic injection of contrast product;
MRI with injection of contrast.
intervention type: Other
intervention name: CT scan
description: CT scan with biphasic injection of contrast product
arm group label: Preoperative evaluation: CT + MRI
intervention type: Other
intervention name: MRI examination
description: MRI with injection of contrast
arm group label: Preoperative evaluation: CT + MRI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Carlier, MD, PhD
role: Principal Investigator
affiliation: Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
last name: Raphaël AMAR, Resident
role: Study Director
affiliation: Service d'Imagerie médicale, Hôpital Raymond Poincaré, Garches
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Myositis
mesh term: Osteoarthritis
mesh term: Myositis Ossificans
sharing ipd: No