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/NCT06029504</url>
    </required_header>
    <id_info>
      <org_study_id>H-18020235</org_study_id>
      <nct_id>NCT06029504</nct_id>
    </id_info>
    <brief_title>Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer</brief_title>
    <acronym>SENTIVUC I</acronym>
    <official_title>Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rigshospitalet, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aarhus University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rigshospitalet, Denmark</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>
        The aim of this study is to investigate whether Sentinel Node biopsy can be performed without&#xD;
        the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer,&#xD;
        unifocal tumor &lt; 4 cm (clinical stage IB and II). Further, to investigate the accuracy of&#xD;
        combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph&#xD;
        nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor&#xD;
        &lt; 4 cm.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Sentinel Node detection rate</measure>
      <time_frame>Three years</time_frame>
      <description>SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor &lt; 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sensitivity, specificity, PPV and NPV</measure>
      <time_frame>Three years</time_frame>
      <description>Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins</description>
    </secondary_outcome>
    <enrollment type="Anticipated">115</enrollment>
    <condition>Vulvar Cancer</condition>
    <condition>Sentinel Lymph Node</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with primary or recurrent vulva cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with primary vulva cancer, FIGO stage IB (tumor &lt; 4 cm)&#xD;
  &#xD;
            -  Patients with unifocal recurrence in the vulva (tumor &lt; 4 cm) located on the side&#xD;
               where the patient is surgically naïve in the groin&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior irradiation of the vulva or groins&#xD;
  &#xD;
            -  Prior SNB or inguinal lymphadenectomy in the relevant groin&#xD;
  &#xD;
            -  Known allergy to ICG or iodine (ICG contains 5% sodium iodine)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ligita P Frøding</last_name>
      <phone>+4522722972</phone>
      <email>ligita.paskeviciute.froeding@regionh.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Copenhagen University Hospital</name>
        <address>
          <city>Copenhagen</city>
          <zip>2100</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ligita P Frøding</last_name>
        <phone>+4522722972</phone>
        <email>ligita.paskeviciute.froeding@regionh.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
      <investigator_full_name>Ligita Paskeviciute Froding</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vulvar Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06029504
  org study id: H-18020235
  nct id: NCT06029504
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate whether Sentinel Node biopsy can be performed without
        the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer,
        unifocal tumor < 4 cm (clinical stage IB and II). Further, to investigate the accuracy of
        combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph
        nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor
        < 4 cm.
  observational model: Cohort
  time perspective: Prospective
  measure: Sentinel Node detection rate
  time frame: Three years
  description: SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor < 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.
  measure: Sensitivity, specificity, PPV and NPV
  time frame: Three years
  description: Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ligita P Frøding
  phone: +4522722972
  email: ligita.paskeviciute.froeding@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Rigshospitalet, Denmark
  investigator full name: Ligita Paskeviciute Froding
  investigator title: MD
  mesh term: Vulvar Neoplasms