<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/NCT02240758</url>
  </required_header>
  <id_info>
    <org_study_id>2013-820</org_study_id>
    <nct_id>NCT02240758</nct_id>
  </id_info>
  <brief_title>Confocal Laser Endomicroscopy for Brain Tumors</brief_title>
  <acronym>GLIOFOCAL</acronym>
  <official_title>INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN</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>
      Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain&#xD;
      lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and&#xD;
      real-time assessment of resections margins during surgery. Probe-based CLE using the&#xD;
      CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the&#xD;
      potential of this technique in improving surgical resection outcome, a feasability study has&#xD;
      to be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</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>To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.</measure>
    <time_frame>End of the surgical procedure</time_frame>
    <description>The technical feasibility will be assessed by the capacity of the CELLVIZIO® system to provide microscopic images of healthy tissue and lesions suspected with malignancy and to match those images with classical histologies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.</measure>
    <time_frame>14 days after inclusion</time_frame>
    <description>Safety will be assessed by the number, type and severity of recorded adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Low Grade Glioma (LGG), High Grade Glioma (HGG)</condition>
  <arm_group>
    <arm_group_label>surgical removal of the tumors+stereotaxic biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)</intervention_name>
    <description>The CELLVIZIO® system (Mauna Kea technology) will be used for confocal endomicroscopy during a surgical procedure (either open surgical approach or stereotaxic biopsy). The probe dedicated to the CELLVIZIO® system will be positioned against the surface of the brain, sequences will be acquired, and finally compared with anatomapathology exams. Two specific medications will be used as contrast agent in the study: Fluorescein FAURE 500mg/5mL IV with a maximum of two doses per patient OR 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.</description>
    <arm_group_label>surgical removal of the tumors+stereotaxic biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
          -  Clinical signs and history of the disease in favor of a HGG, LGG&#xD;
&#xD;
          -  MRI study in favor of a HGG, LGG, meningioma or brain metastasis&#xD;
&#xD;
          -  Affiliated to or beneficiary of a social security system (or equivalent).&#xD;
&#xD;
          -  Patients who have provided written informed consent for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Allergy to fluorescein&#xD;
&#xD;
          -  Previous life-threatening allergic reactions and known hypersensitivity&#xD;
&#xD;
          -  Pregnant or lactating or not using effective contraception;&#xD;
&#xD;
          -  Restricted renal function define by a creatinine clearance &lt; 30ml/min&#xD;
&#xD;
          -  Patients under a beta-blockers treatment&#xD;
&#xD;
          -  Contraindication to do an MRI (pace-maker)&#xD;
&#xD;
          -  Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to&#xD;
             porphyrin, acute or chronic porphyria&#xD;
&#xD;
          -  Minor or adult ward of court (under guardianship or trusteeship)&#xD;
&#xD;
          -  No affiliation to a social security system (or equivalent).&#xD;
&#xD;
          -  Patients who express opposition to participation in the study.&#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>GUYOTAT JACQUES, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>November 25, 2015</last_update_submitted>
  <last_update_submitted_qc>November 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glioma, confocal laser endomicroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</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/NCT02240758
org study id: 2013-820
nct id: NCT02240758
lead sponsor: 
has dmc: No
Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain
      lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and
      real-time assessment of resections margins during surgery. Probe-based CLE using the
      CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the
      potential of this technique in improving surgical resection outcome, a feasability study has
      to be performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
time frame: End of the surgical procedure
description: The technical feasibility will be assessed by the capacity of the CELLVIZIO® system to provide microscopic images of healthy tissue and lesions suspected with malignancy and to match those images with classical histologies.
measure: To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.
time frame: 14 days after inclusion
description: Safety will be assessed by the number, type and severity of recorded adverse events.
arm group label: surgical removal of the tumors+stereotaxic biopsy
arm group type: Experimental
intervention type: Procedure
intervention name: confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)
description: The CELLVIZIO® system (Mauna Kea technology) will be used for confocal endomicroscopy during a surgical procedure (either open surgical approach or stereotaxic biopsy). The probe dedicated to the CELLVIZIO® system will be positioned against the surface of the brain, sequences will be acquired, and finally compared with anatomapathology exams. Two specific medications will be used as contrast agent in the study: Fluorescein FAURE 500mg/5mL IV with a maximum of two doses per patient OR 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.
arm group label: surgical removal of the tumors+stereotaxic biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GUYOTAT JACQUES, MD, PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Glioma