<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/NCT02997553</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00799-42</org_study_id>
    <nct_id>NCT02997553</nct_id>
  </id_info>
  <brief_title>Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery</brief_title>
  <acronym>GASVERT</acronym>
  <official_title>Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</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>
      This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine&#xD;
      green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided&#xD;
      sentinel lymph node biopsy in patients with cancers and subjected to surgery.&#xD;
&#xD;
      The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope&#xD;
      (Techniciun99) in the detection of sentinel lymph nodes will be assess using an &quot;Optonuclear&quot;&#xD;
      probe (EURORAD S.A.) and QUEST camera&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Actual">October 12, 2022</completion_date>
  <primary_completion_date type="Actual">September 19, 2022</primary_completion_date>
  <phase>Phase 3</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>Non-inferiority of indocyanine green guided sentinel lymph node biopsy</measure>
    <time_frame>1 day</time_frame>
    <description>The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively.&#xD;
Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of sentinel lymph node detected</measure>
    <time_frame>1 day</time_frame>
    <description>The total number of sentinel node detected will be assess by the two techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of false negative result</measure>
    <time_frame>1 day</time_frame>
    <description>False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic reactions</measure>
    <time_frame>8 days</time_frame>
    <description>Percentage of patients with allergic reactions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain</measure>
    <time_frame>1 day</time_frame>
    <description>Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fluorescence imaging</measure>
    <time_frame>1 day</time_frame>
    <description>The total number of sentinel node detected by fluorescence imaging</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">744</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Melanoma (Skin)</condition>
  <condition>Squamous Cell Carcinoma, Skin</condition>
  <condition>Cervix Cancer</condition>
  <condition>Endometrium Cancer</condition>
  <condition>Ovary Cancer</condition>
  <condition>Vulva Cancer</condition>
  <condition>Anus Cancer</condition>
  <condition>Rectum Cancer</condition>
  <arm_group>
    <arm_group_label>sentinel lymph node detection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient receive both injections of Technetium99 (standard care) and indocyanine green.&#xD;
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indocyanine green</intervention_name>
    <description>Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)</description>
    <arm_group_label>sentinel lymph node detection</arm_group_label>
    <other_name>Infracyanine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Technetium99</intervention_name>
    <description>Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.&#xD;
Lymphoscintigraphy is performed to identify the sentinel node</description>
    <arm_group_label>sentinel lymph node detection</arm_group_label>
    <other_name>NANOCIS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optonuclear probe</intervention_name>
    <description>The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.</description>
    <arm_group_label>sentinel lymph node detection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Quest Camera</intervention_name>
    <description>The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.</description>
    <arm_group_label>sentinel lymph node detection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  cancer histologically proved&#xD;
&#xD;
          -  patient eligible for sentinel node detection&#xD;
&#xD;
          -  contraceptive methods for men and women of childbearing age&#xD;
&#xD;
          -  signed informed consent form&#xD;
&#xD;
          -  patient affiliated to the social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neoadjuvant chemotherapy or hormone therapy&#xD;
&#xD;
          -  adenopathy (s) clinically suspicious or positively cytopenic&#xD;
&#xD;
          -  women who are pregnant or breast-feeding&#xD;
&#xD;
          -  associated pathology that may prevent patient of receive indocyanine green&#xD;
&#xD;
          -  ongoing participation in another clinical trial with an investigational drug&#xD;
&#xD;
          -  patients deprived of liberty or under supervision&#xD;
&#xD;
          -  impossibility to undergo medical follow-up of the trial for geographical, social or&#xD;
             psychological reasons&#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>MARCHAL FREDERIC, MD, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie de Lorraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandoeuvre-les-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Indocyanine green (ICG)</keyword>
  <keyword>Sentinel lymph node biopsy</keyword>
  <keyword>Technetium99</keyword>
  <keyword>Tumors</keyword>
  <keyword>Optonuclear probe</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Vulvar Neoplasms</mesh_term>
    <mesh_term>Anus Neoplasms</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/NCT02997553
org study id: 2016-A00799-42
nct id: NCT02997553
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine
      green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided
      sentinel lymph node biopsy in patients with cancers and subjected to surgery.

      The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope
      (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear"
      probe (EURORAD S.A.) and QUEST camera
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Non-inferiority of indocyanine green guided sentinel lymph node biopsy
time frame: 1 day
description: The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively.
Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.
measure: Total number of sentinel lymph node detected
time frame: 1 day
description: The total number of sentinel node detected will be assess by the two techniques
measure: Number of false negative result
time frame: 1 day
description: False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node
measure: Allergic reactions
time frame: 8 days
description: Percentage of patients with allergic reactions
measure: Evaluation of pain
time frame: 1 day
description: Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)
measure: fluorescence imaging
time frame: 1 day
description: The total number of sentinel node detected by fluorescence imaging
arm group label: sentinel lymph node detection
arm group type: Experimental
description: Each patient receive both injections of Technetium99 (standard care) and indocyanine green.
The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
intervention type: Drug
intervention name: Indocyanine green
description: Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
arm group label: sentinel lymph node detection
other name: Infracyanine
intervention type: Drug
intervention name: Technetium99
description: Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.
Lymphoscintigraphy is performed to identify the sentinel node
arm group label: sentinel lymph node detection
other name: NANOCIS
intervention type: Device
intervention name: Optonuclear probe
description: The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
arm group label: sentinel lymph node detection
intervention type: Device
intervention name: Quest Camera
description: The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
arm group label: sentinel lymph node detection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MARCHAL FREDERIC, MD, PU-PH
role: Principal Investigator
affiliation: Institut de Cancérologie de Lorraine
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Uterine Cervical Neoplasms
mesh term: Rectal Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Vulvar Neoplasms
mesh term: Anus Neoplasms
sharing ipd: No