<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/NCT01699269</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0125</org_study_id>
    <secondary_id>2011-A0159-40</secondary_id>
    <nct_id>NCT01699269</nct_id>
  </id_info>
  <brief_title>Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging</brief_title>
  <acronym>TeDi-C2</acronym>
  <official_title>Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      This study will examine the use of a variation of standard magnetic resonance imaging (MRI)&#xD;
      called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter&#xD;
      infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor&#xD;
      cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less&#xD;
      anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is&#xD;
      to find if a correlation exists between GA (generalized anisotropy) and the infiltration&#xD;
      percentage of stereotactic peritumoral biopsies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with high grade brain tumor undergo a usual brain tumor MRI protocol as well as a 20&#xD;
      or 60 directions DT-MRI sequence upon patient collaboration. Images are acquired using a 3&#xD;
      Tesla MRI scanner (GE MR750 Discovery).&#xD;
&#xD;
      The usual brain tumor MRI protocol contains the following sequences: 3DT1, Axial T2, Flair,&#xD;
      T2 EG, diffusion (b0-b1000), 3DT1CE.&#xD;
&#xD;
      They will then undergo stereotactic tumor biopsies with Leksell frame mounted.&#xD;
&#xD;
      Biopsy targets will be surgically planned. The coordinates of this first biopsy will be&#xD;
      recorded for later coregistration with DT-MRI datasets.&#xD;
&#xD;
      Histopathologic analysis of the biopsies will be done using usual procedure. various&#xD;
      immunologic markers such as MAP2, Ki67 will be used on the first biopsy sample in order to&#xD;
      estimate the percentage of infiltration (ratio of tumor cells number over total cells&#xD;
      number).&#xD;
&#xD;
      Analysis of DT-MRI datasets will be done using home-made software for high order tensor&#xD;
      resolution and GA estimation at the exact coordinates of the biopsy sites.&#xD;
&#xD;
      Finally a statistical analysis (Pearson or Spearman) will be done to correlate GA and the&#xD;
      infiltration percentage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DTI-MRI</measure>
    <time_frame>at J0</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biopsy</measure>
    <time_frame>at J+1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>count cell</measure>
    <time_frame>at J+10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>datas co-registration</measure>
    <time_frame>at J+20</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>High Grade Brain Tumor</condition>
  <arm_group>
    <arm_group_label>brain tumor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>peritumoral glial cell infiltration</intervention_name>
    <arm_group_label>brain tumor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with high grade brain tumor&#xD;
&#xD;
          -  Age greater than 18 yo and under 85 yo&#xD;
&#xD;
          -  Signed informed consent from patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -Any person with pacemaker, metal implant, claustrophobia, or any other&#xD;
             contraindication for MR examination&#xD;
&#xD;
          -  Severe renal failure&#xD;
&#xD;
          -  Brain tumor biopsy contraindication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Betty JEAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High grade brain tumor</keyword>
  <keyword>Glioma</keyword>
  <keyword>Glioblastoma Multiform</keyword>
  <keyword>Brain Cancer</keyword>
  <keyword>Diffusion-Weighted Magnetic Resonance Imaging</keyword>
  <keyword>High order diffusion tensor</keyword>
  <keyword>Imaging guided biopsy</keyword>
  <keyword>Histopathologic evaluation</keyword>
  <keyword>Infiltration percentage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</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/NCT01699269
org study id: CHU-0125
secondary id: 2011-A0159-40
nct id: NCT01699269
lead sponsor: 
This study will examine the use of a variation of standard magnetic resonance imaging (MRI)
      called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter
      infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor
      cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less
      anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is
      to find if a correlation exists between GA (generalized anisotropy) and the infiltration
      percentage of stereotactic peritumoral biopsies.
Patients with high grade brain tumor undergo a usual brain tumor MRI protocol as well as a 20
      or 60 directions DT-MRI sequence upon patient collaboration. Images are acquired using a 3
      Tesla MRI scanner (GE MR750 Discovery).

      The usual brain tumor MRI protocol contains the following sequences: 3DT1, Axial T2, Flair,
      T2 EG, diffusion (b0-b1000), 3DT1CE.

      They will then undergo stereotactic tumor biopsies with Leksell frame mounted.

      Biopsy targets will be surgically planned. The coordinates of this first biopsy will be
      recorded for later coregistration with DT-MRI datasets.

      Histopathologic analysis of the biopsies will be done using usual procedure. various
      immunologic markers such as MAP2, Ki67 will be used on the first biopsy sample in order to
      estimate the percentage of infiltration (ratio of tumor cells number over total cells
      number).

      Analysis of DT-MRI datasets will be done using home-made software for high order tensor
      resolution and GA estimation at the exact coordinates of the biopsy sites.

      Finally a statistical analysis (Pearson or Spearman) will be done to correlate GA and the
      infiltration percentage.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: Single (Participant)
measure: DTI-MRI
time frame: at J0
measure: Biopsy
time frame: at J+1
measure: count cell
time frame: at J+10
measure: datas co-registration
time frame: at J+20
arm group label: brain tumor
arm group type: Other
intervention type: Other
intervention name: peritumoral glial cell infiltration
arm group label: brain tumor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Betty JEAN
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Brain Neoplasms