<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/NCT02978911</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0759</org_study_id>
    <secondary_id>2015-A01113-46</secondary_id>
    <nct_id>NCT02978911</nct_id>
  </id_info>
  <brief_title>Cranial Nerves Tractography</brief_title>
  <acronym>CN Tracto</acronym>
  <official_title>Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves&#xD;
      or vessels closely surround them. Recently, diffusion tensor imaging has developed with the&#xD;
      tractography following white fibers and visualizing functional tracts. Cranial nerves&#xD;
      tractography could allow predicting their displacement by skull base tumors that may help the&#xD;
      surgeon to spare them along the surgery.&#xD;
&#xD;
      Methods: Preoperative cerebral MRI was performed on patients who presented with skull base&#xD;
      tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32&#xD;
      directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128,&#xD;
      b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was&#xD;
      corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically&#xD;
      tracked with Mrtrix3. Cranial nerves were selected according to their location around the&#xD;
      tumor. The &quot;radiological&quot; expected position of the cranial nerve was compared to its&#xD;
      &quot;operative&quot; real position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2016</start_date>
  <completion_date type="Anticipated">July 12, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 12, 2024</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between the expected and the real position of the selected cranial nerve</measure>
    <time_frame>Date of preoperative MRI (&lt;3 months before the surgery)</time_frame>
    <description>Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between the expected and the real position of the selected cranial nerve</measure>
    <time_frame>at 3 months</time_frame>
    <description>Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative cranial nerve palsy</measure>
    <time_frame>at 3 months</time_frame>
    <description>comparison with preoperative status</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Cranial Nerve Palsy</condition>
  <arm_group>
    <arm_group_label>Skull base tumors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who presented a skull base tumor that requires a surgical removal</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>preoperative cerebral MRI and operative findings</intervention_name>
    <arm_group_label>Skull base tumors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who present a skull base tumor that requires surgical removal&#xD;
&#xD;
          -  Patients adult, informed and agreed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients under 18 years old, unable to legally 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_official>
    <last_name>Timothée Jacquesson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Timothée Jacquesson, MD</last_name>
    <phone>472356921</phone>
    <phone_ext>+33</phone_ext>
    <email>timothee.jacquesson@neurochirurgie.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service de Neurologie B, Hôpital Neurologique, HCL</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Timothée Jacquesson, MD</last_name>
      <phone>472356921</phone>
      <phone_ext>+33</phone_ext>
      <email>timothee.jacquesson@neurochirurgie.fr</email>
    </contact>
    <investigator>
      <last_name>Timothée Jacquesson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cranial Nerve Diseases</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/NCT02978911
org study id: 69HCL16_0759
secondary id: 2015-A01113-46
nct id: NCT02978911
lead sponsor: 
has dmc: No
Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves
      or vessels closely surround them. Recently, diffusion tensor imaging has developed with the
      tractography following white fibers and visualizing functional tracts. Cranial nerves
      tractography could allow predicting their displacement by skull base tumors that may help the
      surgeon to spare them along the surgery.

      Methods: Preoperative cerebral MRI was performed on patients who presented with skull base
      tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32
      directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128,
      b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was
      corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically
      tracked with Mrtrix3. Cranial nerves were selected according to their location around the
      tumor. The "radiological" expected position of the cranial nerve was compared to its
      "operative" real position.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation between the expected and the real position of the selected cranial nerve
time frame: Date of preoperative MRI (<3 months before the surgery)
description: Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.
measure: Correlation between the expected and the real position of the selected cranial nerve
time frame: at 3 months
description: Selection of one or multiples cranial nerves of interest due to their close relationship with the tumor. Comparison of its/their position on MRI and during surgery.
measure: postoperative cranial nerve palsy
time frame: at 3 months
description: comparison with preoperative status
arm group label: Skull base tumors
arm group type: Experimental
description: Patients who presented a skull base tumor that requires a surgical removal
intervention type: Procedure
intervention name: preoperative cerebral MRI and operative findings
arm group label: Skull base tumors
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothée Jacquesson, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Timothée Jacquesson, MD
phone: 472356921
phone ext: +33
email: timothee.jacquesson@neurochirurgie.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Cranial Nerve Diseases
sharing ipd: No