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/NCT06035068</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004163</org_study_id>
      <nct_id>NCT06035068</nct_id>
    </id_info>
    <brief_title>SLN Mapping and ICG Dye for Vulvar Cancer</brief_title>
    <official_title>Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tufts Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tufts Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy.&#xD;
        However, this process can prove somewhat challenging for both patients and medical teams due&#xD;
        to its need for extensive coordination and the assistance of a nuclear medicine team. Some&#xD;
        studies have talked about using a different method to find these lymph nodes using a special&#xD;
        dye called Indocyanine Green (ICG). This method involves shining a special camera on the&#xD;
        skin. So far, no studies have directly compared the ICG method to the standard blue dye. The&#xD;
        ICG camera could make things easier for patients and doctors, and more patients might choose&#xD;
        to have their lymph nodes checked with this new method. The goal of our study is to see if&#xD;
        using the ICG dye is just as good as the standard method of blue dye.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level</measure>
      <time_frame>Data collection at time of surgery</time_frame>
      <description>Report the detection rate of SLNs using ICG dye for sentinel lymph node mapping.&#xD;
  Report the detection rate of SLNs using blue dye for sentinel lymph node mapping.&#xD;
  Compare the two detection rates using a chi-squared test or Fisher's exact test, depending on the sample size.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clustered Analysis at the Hemi-Pelvis Level</measure>
      <time_frame>Data collection at time of surgery</time_frame>
      <description>Use generalized estimating equations (GEE) or mixed-effects logistic regression models to account for the clustering effect.&#xD;
  Include a random effect for each patient to address the correlation between SLNs within the same patient's hemi-pelvis.&#xD;
  Assess the significance of dye type using the Wald test or likelihood ratio test.&#xD;
  Report odds ratios, confidence intervals, and p-values for the effect of dye type on SLN detection.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level</measure>
      <time_frame>Data collection at time of surgery</time_frame>
      <description>Report the proportion of SLNs detected using blue dye in each hemi-pelvis.&#xD;
  Report the proportion of SLNs detected using ICG dye in each hemi-pelvis.&#xD;
  Use a paired t-test or Mcnemar's test to compare the proportions within each hemi-pelvis.&#xD;
  Account for the clustering effect by using mixed-effects models</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye</measure>
      <time_frame>Data collection at time of surgery</time_frame>
      <description>Create a 2x2 contingency table for sensitivity, specificity, and negative predictive value.&#xD;
  Sensitivity = (True Positives) / (True Positives + False Negatives).&#xD;
  Specificity = (True Negatives) / (True Negatives + False Positives).&#xD;
  Negative Predictive Value = (True Negatives) / (True Negatives + False Negatives).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Vulva Cancer</condition>
    <arm_group>
      <arm_group_label>Combined ICG dye and blue tracer dye</arm_group_label>
      <description>This study is being done to see if a different way of finding and removing lymph nodes during surgery, using a special camera and a dye called Indocyanine Green (ICG), works as well as the usual method with blue dye plus a radioactive tracer called radiocolloid. By comparing the two ways directly, we hope to make it simpler for people with vulvar cancer to get their lymph nodes checked during surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Indocyanine green</intervention_name>
      <description>Indocyanine green (ICG) is a fluorescent dye that has been used for the imaging of cancers in the body for more than 30 years.</description>
      <arm_group_label>Combined ICG dye and blue tracer dye</arm_group_label>
      <other_name>ICG dye</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          10 participants fitting the above criteria at Tufts Medical Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Patients with early-stage SCC (diameter &lt;4 cm) of the vulva without suspicious lymph&#xD;
               nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.&#xD;
  &#xD;
            -  Patients with squamous cell carcinoma, depth of invasion &gt; 1mm&#xD;
  &#xD;
            -  Patients with T1 or T2 tumors (FIGO staging) &lt; 4 cm, not encroaching in urethra or&#xD;
               anus with clinically negative inguinofemoral lymph nodes&#xD;
  &#xD;
            -  Localization and size of the tumor are such that perilesional injection of the tracers&#xD;
               at three or four sites is possible&#xD;
  &#xD;
            -  Preoperative imaging do not show enlarged (&lt;1.5 cm)/ suspicious nodes&#xD;
  &#xD;
            -  Willing and able to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inoperable tumors and tumors with diameter &gt; 4 cm&#xD;
  &#xD;
            -  Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious&#xD;
               for metastases or with cytologically proven inguinofemoral lymph node metastases&#xD;
  &#xD;
            -  Radiologically enlarged (&gt;1.5 cm) inguinofemoral lymph nodes&#xD;
  &#xD;
            -  Patients with multifocal tumors&#xD;
  &#xD;
            -  Pregnancy&#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_official>
      <last_name>Rafael Gonzalez, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tufts Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rafael Gonzalez, MD</last_name>
      <phone>617-636-6058</phone>
      <email>rafael.gonzalez@tuftsmedicine.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katina Robison, MD</last_name>
      <email>katina.robison@tuftsmedicine.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tufts Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02111</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alysa St. Charles, MA</last_name>
        <phone>617-636-9897</phone>
        <email>alysa.st.charles@tuftsmedicine.org</email>
      </contact>
      <investigator>
        <last_name>Rafael Gonzalez, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Katina Robison, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Te Grootenhuis NC, van der Zee AG, van Doorn HC, van der Velden J, Vergote I, Zanagnolo V, Baldwin PJ, Gaarenstroom KN, van Dorst EB, Trum JW, Slangen BF, Runnebaum IB, Tamussino K, Hermans RH, Provencher DM, de Bock GH, de Hullu JA, Oonk MH. Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I. Gynecol Oncol. 2016 Jan;140(1):8-14. doi: 10.1016/j.ygyno.2015.09.077. Epub 2015 Sep 30.</citation>
      <PMID>26428940</PMID>
    </reference>
    <reference>
      <citation>Covens A, Vella ET, Kennedy EB, Reade CJ, Jimenez W, Le T. Sentinel lymph node biopsy in vulvar cancer: Systematic review, meta-analysis and guideline recommendations. Gynecol Oncol. 2015 May;137(2):351-61. doi: 10.1016/j.ygyno.2015.02.014. Epub 2015 Feb 20.</citation>
      <PMID>25703673</PMID>
    </reference>
    <reference>
      <citation>Hutteman M, van der Vorst JR, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol. 2012 Jan;206(1):89.e1-5. doi: 10.1016/j.ajog.2011.07.039. Epub 2011 Jul 30.</citation>
      <PMID>21963099</PMID>
    </reference>
    <reference>
      <citation>Crane LM, Themelis G, Arts HJ, Buddingh KT, Brouwers AH, Ntziachristos V, van Dam GM, van der Zee AG. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol. 2011 Feb;120(2):291-5. doi: 10.1016/j.ygyno.2010.10.009. Epub 2010 Nov 6.</citation>
      <PMID>21056907</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vulvar 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>
  
  
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/NCT06035068
  org study id: STUDY00004163
  nct id: NCT06035068
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy.
        However, this process can prove somewhat challenging for both patients and medical teams due
        to its need for extensive coordination and the assistance of a nuclear medicine team. Some
        studies have talked about using a different method to find these lymph nodes using a special
        dye called Indocyanine Green (ICG). This method involves shining a special camera on the
        skin. So far, no studies have directly compared the ICG method to the standard blue dye. The
        ICG camera could make things easier for patients and doctors, and more patients might choose
        to have their lymph nodes checked with this new method. The goal of our study is to see if
        using the ICG dye is just as good as the standard method of blue dye.
  observational model: Cohort
  time perspective: Prospective
  measure: Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level
  time frame: Data collection at time of surgery
  description: Report the detection rate of SLNs using ICG dye for sentinel lymph node mapping.
  Report the detection rate of SLNs using blue dye for sentinel lymph node mapping.
  Compare the two detection rates using a chi-squared test or Fisher's exact test, depending on the sample size.
  measure: Clustered Analysis at the Hemi-Pelvis Level
  time frame: Data collection at time of surgery
  description: Use generalized estimating equations (GEE) or mixed-effects logistic regression models to account for the clustering effect.
  Include a random effect for each patient to address the correlation between SLNs within the same patient's hemi-pelvis.
  Assess the significance of dye type using the Wald test or likelihood ratio test.
  Report odds ratios, confidence intervals, and p-values for the effect of dye type on SLN detection.
  measure: 3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level
  time frame: Data collection at time of surgery
  description: Report the proportion of SLNs detected using blue dye in each hemi-pelvis.
  Report the proportion of SLNs detected using ICG dye in each hemi-pelvis.
  Use a paired t-test or Mcnemar's test to compare the proportions within each hemi-pelvis.
  Account for the clustering effect by using mixed-effects models
  measure: Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye
  time frame: Data collection at time of surgery
  description: Create a 2x2 contingency table for sensitivity, specificity, and negative predictive value.
  Sensitivity = (True Positives) / (True Positives + False Negatives).
  Specificity = (True Negatives) / (True Negatives + False Positives).
  Negative Predictive Value = (True Negatives) / (True Negatives + False Negatives).
  arm group label: Combined ICG dye and blue tracer dye
  description: This study is being done to see if a different way of finding and removing lymph nodes during surgery, using a special camera and a dye called Indocyanine Green (ICG), works as well as the usual method with blue dye plus a radioactive tracer called radiocolloid. By comparing the two ways directly, we hope to make it simpler for people with vulvar cancer to get their lymph nodes checked during surgery.
  intervention type: Drug
  intervention name: Indocyanine green
  description: Indocyanine green (ICG) is a fluorescent dye that has been used for the imaging of cancers in the body for more than 30 years.
  arm group label: Combined ICG dye and blue tracer dye
  other name: ICG dye
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rafael Gonzalez, MD
  role: Principal Investigator
  affiliation: Tufts Medical Center
  last name: Rafael Gonzalez, MD
  phone: 617-636-6058
  email: rafael.gonzalez@tuftsmedicine.org
  last name: Katina Robison, MD
  email: katina.robison@tuftsmedicine.org
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  citation: Te Grootenhuis NC, van der Zee AG, van Doorn HC, van der Velden J, Vergote I, Zanagnolo V, Baldwin PJ, Gaarenstroom KN, van Dorst EB, Trum JW, Slangen BF, Runnebaum IB, Tamussino K, Hermans RH, Provencher DM, de Bock GH, de Hullu JA, Oonk MH. Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I. Gynecol Oncol. 2016 Jan;140(1):8-14. doi: 10.1016/j.ygyno.2015.09.077. Epub 2015 Sep 30.
  PMID: 26428940
  citation: Covens A, Vella ET, Kennedy EB, Reade CJ, Jimenez W, Le T. Sentinel lymph node biopsy in vulvar cancer: Systematic review, meta-analysis and guideline recommendations. Gynecol Oncol. 2015 May;137(2):351-61. doi: 10.1016/j.ygyno.2015.02.014. Epub 2015 Feb 20.
  PMID: 25703673
  citation: Hutteman M, van der Vorst JR, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol. 2012 Jan;206(1):89.e1-5. doi: 10.1016/j.ajog.2011.07.039. Epub 2011 Jul 30.
  PMID: 21963099
  citation: Crane LM, Themelis G, Arts HJ, Buddingh KT, Brouwers AH, Ntziachristos V, van Dam GM, van der Zee AG. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol. 2011 Feb;120(2):291-5. doi: 10.1016/j.ygyno.2010.10.009. Epub 2010 Nov 6.
  PMID: 21056907
  responsible party type: Sponsor
  mesh term: Vulvar Neoplasms
  sharing ipd: No