xml: <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/NCT06018155</url>
    </required_header>
    <id_info>
      <org_study_id>23Neuro02</org_study_id>
      <nct_id>NCT06018155</nct_id>
    </id_info>
    <brief_title>Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation</brief_title>
    <acronym>FIMFos</acronym>
    <official_title>Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Nice</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Nice</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 aim of this study is to evaluate the correlation between the fat infiltration of the&#xD;
        lumbar multifidus muscle and several parameters including the severity of the lumbar&#xD;
        foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included&#xD;
        in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat&#xD;
        infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel&#xD;
        segmentation, semi-automatic segmentation. Correlations between factors influencing the&#xD;
        muscle fat infiltration will be studied by univariate and multivariate statistical analysis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of muscle fat infiltration</measure>
      <time_frame>1 year</time_frame>
      <description>Muscle fat infiltration (%) will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of muscle fat infiltration</measure>
      <time_frame>1 year</time_frame>
      <description>Muscle fat infiltration (%) will be evaluated by 3D segmentation analysis of T2 weighted lumbar spine MRIs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lumbar foraminal stenosis</measure>
      <time_frame>1 year</time_frame>
      <description>Lumbar foraminal stenosis will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs and expressed as a nerve/foramen surface ratio, and by the Lee et al. Classification</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Low Back Pain</condition>
    <condition>Degenerative Condition, Neurologic</condition>
    <arm_group>
      <arm_group_label>Single cohort</arm_group_label>
      <description>Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Spine surgery</intervention_name>
      <description>Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted</description>
      <arm_group_label>Single cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients suffering from low back pain and candidate to a spine surgery included in a&#xD;
          database previously constituted&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Patients suffering from low back pain and candidate to a spine surgery included in a&#xD;
          database previously constituted, for who the following parameters are available: lumbar 3D&#xD;
          MRI with T2 weighted sequences, informed consent.&#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_contact>
      <last_name>Denys Fontaine</last_name>
      <phone>0492038449</phone>
      <phone_ext>+33</phone_ext>
      <email>fontaine.d@chu-nice.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amandine Gavotto</last_name>
      <email>gavotto.a@chu-nice.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital of Nice</name>
        <address>
          <city>Nice</city>
          <zip>06000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neurodegenerative Diseases</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018155
  org study id: 23Neuro02
  nct id: NCT06018155
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the correlation between the fat infiltration of the
        lumbar multifidus muscle and several parameters including the severity of the lumbar
        foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included
        in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat
        infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel
        segmentation, semi-automatic segmentation. Correlations between factors influencing the
        muscle fat infiltration will be studied by univariate and multivariate statistical analysis.
  observational model: Cohort
  time perspective: Retrospective
  measure: Percentage of muscle fat infiltration
  time frame: 1 year
  description: Muscle fat infiltration (%) will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs
  measure: Percentage of muscle fat infiltration
  time frame: 1 year
  description: Muscle fat infiltration (%) will be evaluated by 3D segmentation analysis of T2 weighted lumbar spine MRIs
  measure: Lumbar foraminal stenosis
  time frame: 1 year
  description: Lumbar foraminal stenosis will be evaluated by 2D segmentation analysis of T2 weighted lumbar spine MRIs and expressed as a nerve/foramen surface ratio, and by the Lee et al. Classification
  arm group label: Single cohort
  description: Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted
  intervention type: Other
  intervention name: Spine surgery
  description: Cohort of patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted
  arm group label: Single cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Denys Fontaine
  phone: 0492038449
  phone ext: +33
  email: fontaine.d@chu-nice.fr
  last name: Amandine Gavotto
  email: gavotto.a@chu-nice.fr
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Neurodegenerative Diseases
  mesh term: Low Back Pain
  sharing ipd: No