xml: <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/NCT06039111</url>
    </required_header>
    <id_info>
      <org_study_id>16315</org_study_id>
      <nct_id>NCT06039111</nct_id>
    </id_info>
    <brief_title>Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma</brief_title>
    <acronym>IGNITE-V</acronym>
    <official_title>Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hamilton Health Sciences Corporation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Juravinski Cancer Centre Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hamilton Health Sciences Corporation</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to confirm prospectively if the use of near infrared-indocyanine&#xD;
        green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual&#xD;
        technique for sentinel lymph node detection in early stage vulvar cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>Phase 2</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>false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin</measure>
      <time_frame>2 years</time_frame>
      <description>This will be calculated as the number of groins for which positive SLN were missed using ICG alone; i.e. the number of groins for which ICG did not detect a positive SLN but was detected by ICG and Technetium, divided by the number of groins for which surgery was performed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>1. The proportion of positive SLN detected by ICG for each groin divided by the total number of positive SLN detected using ICG and Technetium.</measure>
      <time_frame>2 years</time_frame>
      <description>the unit of analysis is the number of SLN for each groin.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>2. The proportion of groins for which all SLN extracted were identified by ICG.</measure>
      <time_frame>2 years</time_frame>
      <description>This is defined as the number of groins for whom, all SLN extracted were identified by ICG compared to the number of SLN extracted by ICG and Technetium.</description>
    </other_outcome>
    <other_outcome>
      <measure>3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.</measure>
      <time_frame>2 years</time_frame>
      <description>The unit of analysis is the number of SLN for each groin.</description>
    </other_outcome>
    <other_outcome>
      <measure>4. Rate of successful mapping of at least 1 SLN (per groin)</measure>
      <time_frame>2 years</time_frame>
      <description>proportion</description>
    </other_outcome>
    <other_outcome>
      <measure>5. The specificity of positive SLN detected and number of SLN extracted by ICG will also be calculated, looking at the number of SLN which were detected by ICG alone.</measure>
      <time_frame>2 years</time_frame>
      <description>Appropriate caution will be performed when looking at this outcome, understanding that evaluation of whether Technetium detected a SLN will be performed after the SLN is extracted, which is not consistent with normal practice and could be subject to bias.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Vulvar Cancer</condition>
    <arm_group>
      <arm_group_label>Sequential ICG and Technetium Detection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ICG alone</intervention_name>
      <description>SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy</description>
      <arm_group_label>Sequential ICG and Technetium Detection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Adult women (18 years of age) with FIGO Stage IB (&gt; 1 mm depth of invasion) and small Stage&#xD;
          II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the&#xD;
          Sentinel lymph node technique will be included (Negative clinical groin examination and/or&#xD;
          imaging and primary unifocal vulvar tumor size of &lt; 4 cm).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or&#xD;
          hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hamilton Health Sciences Corporation</investigator_affiliation>
      <investigator_full_name>Andra Nica</investigator_full_name>
      <investigator_title>Gynecologic Oncologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Vulvar Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039111
  org study id: 16315
  nct id: NCT06039111
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The aim of this study is to confirm prospectively if the use of near infrared-indocyanine
        green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual
        technique for sentinel lymph node detection in early stage vulvar cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin
  time frame: 2 years
  description: This will be calculated as the number of groins for which positive SLN were missed using ICG alone; i.e. the number of groins for which ICG did not detect a positive SLN but was detected by ICG and Technetium, divided by the number of groins for which surgery was performed.
  measure: 1. The proportion of positive SLN detected by ICG for each groin divided by the total number of positive SLN detected using ICG and Technetium.
  time frame: 2 years
  description: the unit of analysis is the number of SLN for each groin.
  measure: 2. The proportion of groins for which all SLN extracted were identified by ICG.
  time frame: 2 years
  description: This is defined as the number of groins for whom, all SLN extracted were identified by ICG compared to the number of SLN extracted by ICG and Technetium.
  measure: 3. The proportion of SLN extracted by ICG for each groin divided by the total number of SLN extracted using ICG and Technetium.
  time frame: 2 years
  description: The unit of analysis is the number of SLN for each groin.
  measure: 4. Rate of successful mapping of at least 1 SLN (per groin)
  time frame: 2 years
  description: proportion
  measure: 5. The specificity of positive SLN detected and number of SLN extracted by ICG will also be calculated, looking at the number of SLN which were detected by ICG alone.
  time frame: 2 years
  description: Appropriate caution will be performed when looking at this outcome, understanding that evaluation of whether Technetium detected a SLN will be performed after the SLN is extracted, which is not consistent with normal practice and could be subject to bias.
  arm group label: Sequential ICG and Technetium Detection
  arm group type: Experimental
  intervention type: Procedure
  intervention name: ICG alone
  description: SLNs will be detected with ICG alone, labelled as such, and subsequent to that tested with Gamma probe for accuracy
  arm group label: Sequential ICG and Technetium Detection
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Hamilton Health Sciences Corporation
  investigator full name: Andra Nica
  investigator title: Gynecologic Oncologist
  mesh term: Carcinoma, Squamous Cell
  mesh term: Vulvar Neoplasms
  sharing ipd: Undecided