<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/NCT01673022</url>
  </required_header>
  <id_info>
    <org_study_id>1204008493</org_study_id>
    <nct_id>NCT01673022</nct_id>
  </id_info>
  <brief_title>Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging</brief_title>
  <acronym>FIRES</acronym>
  <official_title>Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging for Detecting Metastatic Endometrial and Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Description:&#xD;
&#xD;
      This is a multi-institutional study investigating the sensitivity and negative predictive&#xD;
      value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after&#xD;
      cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or&#xD;
      cervical cancer at the time of their robotic surgical staging.&#xD;
&#xD;
      Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by&#xD;
      sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph&#xD;
      nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel&#xD;
      pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine&#xD;
      pathologic processing according to standard of care for these surgical procedures. The&#xD;
      pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity&#xD;
      and negative predictive value in their ability to detect metastatic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brief Summary:&#xD;
&#xD;
      Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery&#xD;
      to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after&#xD;
      they are asleep from anesthesia prior to performing the surgery. During the surgery, the&#xD;
      surgeon will activate the robotic camera that is being used to visualize the internal organs&#xD;
      changing it to a special mode of imaging called near infrared imaging. The near infrared&#xD;
      imaging will allow the surgeon to see where the dye that was injected into the cervix has&#xD;
      spread. The dye travels through vessels called lymphatic channels to nodules called &quot;sentinel&#xD;
      lymph nodes&quot;. These are the tissues the surgeon is most interested in removing in order to&#xD;
      see if there has been spread of their cancer to those nodules. The dye that travels to the&#xD;
      lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are&#xD;
      indistinguishable from the surrounding fatty tissue.&#xD;
&#xD;
      The nodes that have dye in them will be removed from the patient and sent to the pathologist,&#xD;
      where they will be very closely examined, called ultrasectioning, for cancer spread. The&#xD;
      surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue&#xD;
      that surrounded the sentinel lymph node that did not stain with the dye), as these are the&#xD;
      &quot;non-sentinel lymph nodes&quot;, and are the tissue that is traditionally removed with endometrial&#xD;
      and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will&#xD;
      also be examined for evidence of cancer spread. The researchers will compare the pathology&#xD;
      results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the&#xD;
      sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in&#xD;
      the non-sentinel nodes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the Sensitivity of the Sentinel Lymph Node</measure>
    <time_frame>3 years</time_frame>
    <description>To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">430</enrollment>
  <condition>Endometrial Cancer</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>IC Green Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One arm only: Receives IC Green for testing of study objective</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IC Green</intervention_name>
    <description>IC Green</description>
    <arm_group_label>IC Green Arm</arm_group_label>
    <other_name>indocyanine green for injection, USP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be women 18 years and older who have biopsy proven endometrial or&#xD;
             cervical carcinoma (of any histologic subtype).&#xD;
&#xD;
          -  Surgical staging with the da Vinci Si robotic tool must be planned with a planned&#xD;
             pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy&#xD;
&#xD;
          -  Patients must meet criteria for robotic surgical approach:&#xD;
&#xD;
          -  Patients must have either a clinical stage I endometrial (of any histologic grade) or&#xD;
             FIGO stage IA2 or IB1 (&lt;4cm) cervical squamous, adenocarcinoma or adenosquamous&#xD;
             carcinoma.&#xD;
&#xD;
          -  Patients must be able to sign an informed consent in English language.&#xD;
&#xD;
          -  Patients with known liver disease will require normal range liver function tests as&#xD;
             determined by pre-operative labs drawn within 30 days of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have iodide allergies&#xD;
&#xD;
          -  Patients who have had previous retroperitoneal surgery&#xD;
&#xD;
          -  Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their&#xD;
             surgical staging.&#xD;
&#xD;
          -  Patients who have received previous treatment for their endometrial or cervical cancer&#xD;
             (particularly hysterectomy or pelvic radiation).&#xD;
&#xD;
          -  Patients who are pregnant.&#xD;
&#xD;
          -  Patients with documented liver disease who have abnormalities of liver function tests.&#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>Emma Rossi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USA Mitchell Cancer Institute</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunrise Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri Health Good Smaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>December 19, 2017</results_first_submitted>
  <results_first_submitted_qc>June 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2018</results_first_posted>
  <last_update_submitted>June 27, 2018</last_update_submitted>
  <last_update_submitted_qc>June 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2018</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>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IC-GREEN® (Indocyanine Green) Arm</title>
          <description>One arm only: Receives IC-GREEN® (Indocyanine green) for testing of study objective&#xD;
IC-GREEN®: Indocyanine 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="430"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="422"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IC Green Arm</title>
          <description>One arm only: Receives IC Green for testing of study objective&#xD;
IC Green: IC Green</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="430"/>
          </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="293"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" spread="28"/>
                  </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="430"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Estimate the Sensitivity of the Sentinel Lymph Node</title>
        <description>To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.</description>
        <time_frame>3 years</time_frame>
        <population>Sensitivity of the sentinel lymph node</population>
        <group_list>
          <group group_id="O1">
            <title>IC Green (Indocyanine Green) Arm</title>
            <description>One arm only: Receives IC Green (indocyanine green) )for testing of study objective&#xD;
IC Green: IC Green (indocyanine green)</description>
          </group>
        </group_list>
        <measure>
          <title>Estimate the Sensitivity of the Sentinel Lymph Node</title>
          <description>To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.</description>
          <population>Sensitivity of the sentinel lymph node</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="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>IC Green Arm</title>
          <description>One arm only: Receives IC Green for testing of study objective&#xD;
IC Green: IC Green</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>postoperative neurological disorder</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ureteral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>postoperative respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>lymphedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="430"/>
              </event>
              <event>
                <sub_title>hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="17" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="430"/>
              </event>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
              <event>
                <sub_title>hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pulmonary edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="430"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="430"/>
              </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>Research Coordinator</name_or_title>
      <organization>Indiana University School of Medicine</organization>
      <phone>317-944-2654</phone>
      <email>jmvinter@iupui.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/NCT01673022
org study id: 1204008493
nct id: NCT01673022
lead sponsor: 
has dmc: Yes
Description:

      This is a multi-institutional study investigating the sensitivity and negative predictive
      value of sentinel lymph nodes mapped with robotic assisted near infrared imaging after
      cervical injection of indocyanine green (ICG) dye for women with stage I endometrial or
      cervical cancer at the time of their robotic surgical staging.

      Patients will receive cervical injection of 1mg ICG after induction of anesthesia followed by
      sentinel lymph node mapping using robotic assisted fluorescence imaging. The sentinel lymph
      nodes identified will be removed and sent for ultraprocessing by pathology. The non-sentinel
      pelvic and para-aortic (if indicated) non-sentinel nodes will be removed and sent for routine
      pathologic processing according to standard of care for these surgical procedures. The
      pathologic results of the sentinel and non-sentinel nodes will be evaluated for sensitivity
      and negative predictive value in their ability to detect metastatic disease.
Brief Summary:

      Patients with early stage endometrial and cervical cancer who are undergoing robotic surgery
      to remove the uterus, cervix and lymph nodes will have dye injected into the cervix after
      they are asleep from anesthesia prior to performing the surgery. During the surgery, the
      surgeon will activate the robotic camera that is being used to visualize the internal organs
      changing it to a special mode of imaging called near infrared imaging. The near infrared
      imaging will allow the surgeon to see where the dye that was injected into the cervix has
      spread. The dye travels through vessels called lymphatic channels to nodules called "sentinel
      lymph nodes". These are the tissues the surgeon is most interested in removing in order to
      see if there has been spread of their cancer to those nodules. The dye that travels to the
      lymph nodes makes them more easily visible to the surgeon. Without the dye, these nodes are
      indistinguishable from the surrounding fatty tissue.

      The nodes that have dye in them will be removed from the patient and sent to the pathologist,
      where they will be very closely examined, called ultrasectioning, for cancer spread. The
      surgeon will remove the remaining lymphatic tissue (all of the fatty and lymphatic tissue
      that surrounded the sentinel lymph node that did not stain with the dye), as these are the
      "non-sentinel lymph nodes", and are the tissue that is traditionally removed with endometrial
      and cervical cancer surgery as part of standard of care. These non-sentinel lymph nodes will
      also be examined for evidence of cancer spread. The researchers will compare the pathology
      results from the sentinel nodes and non-sentinel nodes. The researchers hypothesize that the
      sentinel nodes contain cancer cells at least 90% of the time when there is cancer found in
      the non-sentinel nodes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Estimate the Sensitivity of the Sentinel Lymph Node
time frame: 3 years
description: To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.
arm group label: IC Green Arm
arm group type: Experimental
description: One arm only: Receives IC Green for testing of study objective
intervention type: Drug
intervention name: IC Green
description: IC Green
arm group label: IC Green Arm
other name: indocyanine green for injection, USP
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emma Rossi, MD
role: Principal Investigator
affiliation: Indiana University
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country: United States
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Endometrial Neoplasms
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 