<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/NCT04400292</url>
  </required_header>
  <id_info>
    <org_study_id>20-201</org_study_id>
    <nct_id>NCT04400292</nct_id>
  </id_info>
  <brief_title>Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging</brief_title>
  <official_title>Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG&#xD;
      dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer&#xD;
      that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer,&#xD;
      surgeons in the future could identify the sentinel lymph nodes and only remove these instead&#xD;
      of removing all the lymph nodes which is currently done.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This will be a prospective single-arm study.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of lymph nodes visualized to be fluorescent and nonfluorescent.</measure>
    <time_frame>1 year</time_frame>
    <description>Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>SLN mapping by NIR with ICG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Injection of indocyanine green (ICG)dye</intervention_name>
    <description>Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.</description>
    <arm_group_label>SLN mapping by NIR with ICG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Near-Infrared Image-Guided</intervention_name>
    <description>Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.</description>
    <arm_group_label>SLN mapping by NIR with ICG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sentinel Lymph Node (SLN) mapping</intervention_name>
    <description>Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.</description>
    <arm_group_label>SLN mapping by NIR with ICG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or&#xD;
             esophagogastric junction , with a plan to undergo minimally invasive esophagectomy.&#xD;
&#xD;
          -  All patients with Stage IVA (AJCC Cancer Staging Manual, 8th edition) disease will be&#xD;
             eligible&#xD;
&#xD;
          -  ≥18 years of age.&#xD;
&#xD;
          -  Documented, signed, and dated informed consent, obtained before any procedures, for&#xD;
             the proposed research study and for standard surgical resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No plan to undergo surgical resection.&#xD;
&#xD;
          -  Severe iodide or seafood allergy.&#xD;
&#xD;
          -  Women of childbearing potential without a negative pregnancy test; or women who are&#xD;
             lactating.&#xD;
&#xD;
          -  Prior diagnosis of severe hepatic or renal dysfunction.&#xD;
&#xD;
          -  Patients with Stage IVB or M1 disease (AJCC Cancer Staging Manual, 8th edition)&#xD;
&#xD;
          -  Patients with local recurrence and planning to undergo salvage esophagectomy&#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>Daniela Molena, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniela Molena, MD</last_name>
    <phone>212-639-3870</phone>
    <email>molenad@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Smita Sihag, MD, MPH</last_name>
    <phone>212-639-3309</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Molena, MD</last_name>
      <phone>212-639-3870</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sentinel Lymph Node Mapping</keyword>
  <keyword>lymphadenectomy</keyword>
  <keyword>esophagectomy</keyword>
  <keyword>ICG Injection</keyword>
  <keyword>Intraoperative NIR Imaging</keyword>
  <keyword>20-201</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04400292
org study id: 20-201
nct id: NCT04400292
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG
      dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer
      that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer,
      surgeons in the future could identify the sentinel lymph nodes and only remove these instead
      of removing all the lymph nodes which is currently done.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a prospective single-arm study.
primary purpose: Diagnostic
masking: None (Open Label)
measure: The number of lymph nodes visualized to be fluorescent and nonfluorescent.
time frame: 1 year
description: Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.
arm group label: SLN mapping by NIR with ICG
arm group type: Experimental
description: Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer.
intervention type: Other
intervention name: Injection of indocyanine green (ICG)dye
description: Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.
arm group label: SLN mapping by NIR with ICG
intervention type: Device
intervention name: Near-Infrared Image-Guided
description: Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.
arm group label: SLN mapping by NIR with ICG
intervention type: Procedure
intervention name: Sentinel Lymph Node (SLN) mapping
description: Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.
arm group label: SLN mapping by NIR with ICG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniela Molena, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Daniela Molena, MD
phone: 212-639-3870
email: molenad@mskcc.org
last name: Smita Sihag, MD, MPH
phone: 212-639-3309
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.