<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/NCT03291977</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9758_FLEGME</org_study_id>
    <nct_id>NCT03291977</nct_id>
  </id_info>
  <brief_title>Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)</brief_title>
  <acronym>FLEGME</acronym>
  <official_title>Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most&#xD;
      widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma&#xD;
      cells through a metabolic abnormality and thus helps in defining tumoral edges through a&#xD;
      modified microscope. A multicentric, randomized study comparing 5ala guided surgery with&#xD;
      conventional procedures showed that this technique doubles the rate of complete removal on&#xD;
      post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free&#xD;
      survival. More recently, fluorescein appeared as an interesting alternative fluorophore for&#xD;
      glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its&#xD;
      use remains scarcely studied and its clinical benefit unsure. In that context, the&#xD;
      investigators propose a randomized trial comparing conventional &quot; white light &quot; surgery with&#xD;
      fluorescein-guided resection of glioblastomas, in order to assess the relevance of this&#xD;
      technique in glioblastomas removal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">January 18, 2022</completion_date>
  <primary_completion_date type="Actual">January 18, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gross total removal rates</measure>
    <time_frame>under 72 hours post-op</time_frame>
    <description>assessed by the absence of residual contrast enhancement on early post-operative MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute volumes of tumor remnants</measure>
    <time_frame>under 72 hours post-op</time_frame>
    <description>assessed in cm3 on early post-operative MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative volumes of tumor remnants</measure>
    <time_frame>under 72 hours post-op</time_frame>
    <description>assessed in % on early post-operative MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of new neurological deficits</measure>
    <time_frame>under 72 hours post-op</time_frame>
    <description>assessed by the NIHSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of anaphylactic events related to the administration of fluorescein</measure>
    <time_frame>under 72 hours post-op</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Glioblastoma, Adult</condition>
  <arm_group>
    <arm_group_label>Fluorescein sodique FAURE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White-light surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control arm, the surgery will be performed under classical conditions (so-called &quot; white-light &quot; surgery).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorescéine Sodique Faure</intervention_name>
    <description>Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.</description>
    <arm_group_label>Fluorescein sodique FAURE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>White-light surgery</intervention_name>
    <description>The surgery will be performed under classical conditions</description>
    <arm_group_label>White-light surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 79&#xD;
&#xD;
          -  Karnofsky index &gt; 70 %&#xD;
&#xD;
          -  Brain MRI showing a parenchymal lesion with typical features of glioblastoma, &lt; 1week&#xD;
&#xD;
          -  Achievable gross total removal, as assessed by the neurosurgical staff&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to fluorescein&#xD;
&#xD;
          -  Contraindication to MRI&#xD;
&#xD;
          -  History of brain surgery &lt;6 months&#xD;
&#xD;
          -  Guardianship, tutelage or deprivation of liberty&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Participation to other interventional clinical studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre-Jean LE RESTE, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgery - glioblastoma - fluorescein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</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/NCT03291977
org study id: 35RC16_9758_FLEGME
nct id: NCT03291977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most
      widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma
      cells through a metabolic abnormality and thus helps in defining tumoral edges through a
      modified microscope. A multicentric, randomized study comparing 5ala guided surgery with
      conventional procedures showed that this technique doubles the rate of complete removal on
      post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free
      survival. More recently, fluorescein appeared as an interesting alternative fluorophore for
      glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its
      use remains scarcely studied and its clinical benefit unsure. In that context, the
      investigators propose a randomized trial comparing conventional " white light " surgery with
      fluorescein-guided resection of glioblastomas, in order to assess the relevance of this
      technique in glioblastomas removal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gross total removal rates
time frame: under 72 hours post-op
description: assessed by the absence of residual contrast enhancement on early post-operative MRI
measure: Absolute volumes of tumor remnants
time frame: under 72 hours post-op
description: assessed in cm3 on early post-operative MRI
measure: Relative volumes of tumor remnants
time frame: under 72 hours post-op
description: assessed in % on early post-operative MRI
measure: Occurrence of new neurological deficits
time frame: under 72 hours post-op
description: assessed by the NIHSS
measure: Occurrence of anaphylactic events related to the administration of fluorescein
time frame: under 72 hours post-op
arm group label: Fluorescein sodique FAURE
arm group type: Experimental
description: Fluorescein (Fluorescéine sodique FAURE) will be given intravenously during the induction of the anesthesia
arm group label: White-light surgery
arm group type: Active Comparator
description: In the control arm, the surgery will be performed under classical conditions (so-called " white-light " surgery).
intervention type: Drug
intervention name: Fluorescéine Sodique Faure
description: Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.
arm group label: Fluorescein sodique FAURE
intervention type: Procedure
intervention name: White-light surgery
description: The surgery will be performed under classical conditions
arm group label: White-light surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Pierre-Jean LE RESTE, Dr
role: Principal Investigator
affiliation: CHU Rennes
facility: 
country: France
responsible party type: Sponsor
mesh term: Glioblastoma
sharing ipd: No