<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/NCT03294330</url>
  </required_header>
  <id_info>
    <org_study_id>7046</org_study_id>
    <nct_id>NCT03294330</nct_id>
  </id_info>
  <brief_title>SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer</brief_title>
  <acronym>SPYX</acronym>
  <official_title>SPY-X: A Study to Assess the Feasibility of Using Real-time Fluorescence Lymphangiography Alone for Sentinel Node Localization in Patients With Melanoma or Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vassar Brothers Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine if fluorescence lymphangiography can be used&#xD;
      alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis&#xD;
      is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence&#xD;
      lymphangiography, without the need for technetium99 and a gamma probe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From the subject's viewpoint, the course of events in this study will be no different than&#xD;
      usual care and sentinel node biopsy. Subjects will have a dermal injection of technetium99&#xD;
      (tech99) at the melanoma tumor site prior to surgery (either the day before, or morning of&#xD;
      surgery) or a subareolar injection if breast cancer. The surgeon will not look at the&#xD;
      lymphoscintigraphy films, and the radiologist should not mark the skin. When the subject is&#xD;
      in the operating room and appropriately sedated or anesthetized, tthey will receive a dermal&#xD;
      injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if&#xD;
      breast cancer. Incision is made in the axilla or groin, and the SPY machine is positioned&#xD;
      over the lymph node basin. Real-time lymphangiography (SPY) is used to identify sentinel&#xD;
      nodes. Any fluorescent nodes should be resected and are considered sentinel nodes. The&#xD;
      absolute fluorescence will be quantified for each sentinel node. Absolute fluorescence is&#xD;
      calculated by the SPY machine.&#xD;
&#xD;
      After the sentinel lymphadenectomy is complete but prior to closing skin, the excised lymph&#xD;
      nodes will be examined with the gamma probe (detects tech99 signal) to confirm that they are&#xD;
      sentinel nodes. If the node does not have a signal with the gamma probe (but is fluorescent)&#xD;
      it is still considered a sentinel node. The lymph node basin will also be examined with the&#xD;
      gamma probe, to insure that no sentinel nodes are missed. If a gamma positive sentinel node&#xD;
      is identified in the lymph node basin, it should be resected and imaged with SPY. If no&#xD;
      sentinel nodes are able to be identified with fluorescent imaging, the gamma probe will be&#xD;
      used as per usual practice. The surgeon should spend no more than 30 minutes using SPY to&#xD;
      identify sentinel nodes. If after 30 minutes no sentinel node is found, the gamma probe&#xD;
      should be used. The data collection form should be completed for each case.&#xD;
&#xD;
      The investigators intend to enroll at least 48 subjects. In order to insure that the data&#xD;
      collected accurately represents the effectiveness of the SPY machine, each surgeon will be&#xD;
      required to enroll at least 8 subjects into the study. Sentinel node biopsy is a routine&#xD;
      surgical procedure, and all involved PIs are experienced in performing sentinel node biopsy.&#xD;
      While fluorescence imaging intra-op is novel, the actual procedure itself is no different.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">November 2, 2021</completion_date>
  <primary_completion_date type="Actual">September 17, 2021</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>Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone</measure>
    <time_frame>Intraoperative, up to 1 hour</time_frame>
    <description>The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Four weeks</time_frame>
    <description>Any adverse events related to ICG or sentinel node biopsy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Sentinel Lymph Node</condition>
  <condition>Melanoma (Skin)</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with Melanoma or Breast Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IC-Green KIT</intervention_name>
    <description>fluorescence lymphangiography with the use of IC-Green</description>
    <arm_group_label>Patients with Melanoma or Breast Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with melanoma or breast cancer who meet criteria for and consent to sentinel&#xD;
             node biopsy.The melanoma should be located on the upper extremity between and&#xD;
             including the wrist and shoulder, or the lower extremity between and including the&#xD;
             ankle and groin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine&#xD;
             green or sodium iodide. Pregnant and nursing women. Patients who have had a prior&#xD;
             sentinel node biopsy in the same nodal basin.&#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>Colette Pameijer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State Hershey Medical Center and College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vassar Brothers Medical Center</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PennState Health Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>September 9, 2022</results_first_submitted>
  <results_first_submitted_qc>December 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 12, 2023</results_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Colette Pameijer</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 27, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03294330/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects recruited in surgical clinic between 10/11/2017 - 9/13/2021</recruitment_details>
      <pre_assignment_details>One subject withdrew due to change in OR location and lack of SPY machine. No other relevant events.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Patients With Melanoma or Breast Cancer</title>
          <description>The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.&#xD;
IC-Green KIT: fluorescence lymphangiography with the use of IC-Green</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patients With Melanoma or Breast Cancer</title>
          <description>The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.&#xD;
IC-Green KIT: fluorescence lymphangiography with the use of IC-Green</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.5" lower_limit="28" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.3" lower_limit="18.5" upper_limit="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor location</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Upper extremity</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lower extremity</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone</title>
        <description>The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.</description>
        <time_frame>Intraoperative, up to 1 hour</time_frame>
        <population>Patients with cutaneous melanoma of the extremity.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With Melanoma or Breast Cancer</title>
            <description>The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.&#xD;
IC-Green KIT: fluorescence lymphangiography with the use of IC-Green</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone</title>
          <description>The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.</description>
          <population>Patients with cutaneous melanoma of the extremity.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First sentinel node</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second sentinel node</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third sentinel node</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Any adverse events related to ICG or sentinel node biopsy.</description>
        <time_frame>Four weeks</time_frame>
        <population>Patients with cutaneous melanoma of extremity who had a sentinel node biopsy</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With Melanoma or Breast Cancer</title>
            <description>The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.&#xD;
IC-Green KIT: fluorescence lymphangiography with the use of IC-Green</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Any adverse events related to ICG or sentinel node biopsy.</description>
          <population>Patients with cutaneous melanoma of extremity who had a sentinel node biopsy</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One month after surgery.</time_frame>
      <desc>Adverse events were collected intraop, postop and at the time of follow-up visit between 2-4 weeks after surgery.</desc>
      <group_list>
        <group group_id="E1">
          <title>Patients With Melanoma or Breast Cancer</title>
          <description>The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.&#xD;
IC-Green KIT: fluorescence lymphangiography with the use of IC-Green</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>seroma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>SSI</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Colette Pameijer</name_or_title>
      <organization>Penn State College of Medicine</organization>
      <phone>717-531-5272</phone>
      <email>cpameijer@pennstatehealth.psu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03294330
org study id: 7046
nct id: NCT03294330
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to determine if fluorescence lymphangiography can be used
      alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis
      is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence
      lymphangiography, without the need for technetium99 and a gamma probe.
From the subject's viewpoint, the course of events in this study will be no different than
      usual care and sentinel node biopsy. Subjects will have a dermal injection of technetium99
      (tech99) at the melanoma tumor site prior to surgery (either the day before, or morning of
      surgery) or a subareolar injection if breast cancer. The surgeon will not look at the
      lymphoscintigraphy films, and the radiologist should not mark the skin. When the subject is
      in the operating room and appropriately sedated or anesthetized, tthey will receive a dermal
      injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if
      breast cancer. Incision is made in the axilla or groin, and the SPY machine is positioned
      over the lymph node basin. Real-time lymphangiography (SPY) is used to identify sentinel
      nodes. Any fluorescent nodes should be resected and are considered sentinel nodes. The
      absolute fluorescence will be quantified for each sentinel node. Absolute fluorescence is
      calculated by the SPY machine.

      After the sentinel lymphadenectomy is complete but prior to closing skin, the excised lymph
      nodes will be examined with the gamma probe (detects tech99 signal) to confirm that they are
      sentinel nodes. If the node does not have a signal with the gamma probe (but is fluorescent)
      it is still considered a sentinel node. The lymph node basin will also be examined with the
      gamma probe, to insure that no sentinel nodes are missed. If a gamma positive sentinel node
      is identified in the lymph node basin, it should be resected and imaged with SPY. If no
      sentinel nodes are able to be identified with fluorescent imaging, the gamma probe will be
      used as per usual practice. The surgeon should spend no more than 30 minutes using SPY to
      identify sentinel nodes. If after 30 minutes no sentinel node is found, the gamma probe
      should be used. The data collection form should be completed for each case.

      The investigators intend to enroll at least 48 subjects. In order to insure that the data
      collected accurately represents the effectiveness of the SPY machine, each surgeon will be
      required to enroll at least 8 subjects into the study. Sentinel node biopsy is a routine
      surgical procedure, and all involved PIs are experienced in performing sentinel node biopsy.
      While fluorescence imaging intra-op is novel, the actual procedure itself is no different.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone
time frame: Intraoperative, up to 1 hour
description: The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.
measure: Adverse Events
time frame: Four weeks
description: Any adverse events related to ICG or sentinel node biopsy.
arm group label: Patients with Melanoma or Breast Cancer
arm group type: Experimental
description: The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.
intervention type: Drug
intervention name: IC-Green KIT
description: fluorescence lymphangiography with the use of IC-Green
arm group label: Patients with Melanoma or Breast Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colette Pameijer, MD
role: Principal Investigator
affiliation: Penn State Hershey Medical Center and College of Medicine
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Colette Pameijer
investigator title: Medical Doctor
mesh term: Breast Neoplasms
mesh term: Melanoma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 