<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/NCT02218242</url>
  </required_header>
  <id_info>
    <org_study_id>13-LUN-95-MCC</org_study_id>
    <nct_id>NCT02218242</nct_id>
  </id_info>
  <brief_title>Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound</brief_title>
  <official_title>A Single-arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joel Thompson, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will&#xD;
      receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph&#xD;
      node dissection. After completion of the standard of care, intraoperative ultrasound will be&#xD;
      used to evaluate lymph node stations for the presence of any missed lymph nodes with&#xD;
      particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data&#xD;
      will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of&#xD;
      ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is&#xD;
      hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted&#xD;
      thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes&#xD;
      in non-small cell lung cancer patients undergoing definitive surgical resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to enroll enough participants&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">June 27, 2018</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of Occult Pathologic N2 Lymph Nodes</measure>
    <time_frame>At time of surgery</time_frame>
    <description>Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this study have elected to have surgical resection of non-small cell lung cancer tumors as part of their standard of care. During that surgical procedure, participants will also receive laparoscopic intraoperative ultrasound to assess the thoracic wall lymph nodes as part of the experimental procedure. The ultrasound procedure will add about 15 minutes to the total surgical time. Because it is laparoscopic and utilizes non-ionizing radiation, the risk to the participant is minimal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraoperative ultrasound</intervention_name>
    <description>Intraoperative ultrasound will be performed at the completion of the standard lung cancer resection with mediastinal lymph node dissection. This evaluation will be performed by a different surgeon from the primary surgeon performing the operation to minimize operator variability with the ultrasound system and help control for bias. Additional lymph nodes identified will be resected and sent for pathologic evaluation. It is anticipated that this additional evaluation and treatment should take no more than 30 minutes and as such a time limit of 30 minutes from introduction of the ultrasound probe into the surgical field will be set.</description>
    <arm_group_label>Ultrasound</arm_group_label>
    <other_name>B-K Medical/Analogic 8666-Radio Frequency laparoscopic ultrasound transducer and the bedside flex Focus 1202 imaging system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age ≥18 years. Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%,&#xD;
        see Appendix A).&#xD;
&#xD;
        Life expectancy of greater than 3 months&#xD;
&#xD;
        Patients be able to undergo VATS resection as defined below:&#xD;
&#xD;
          -  Preoperative Forced Expiratory Volume at one second ≥ 40% predicted&#xD;
&#xD;
          -  OR&#xD;
&#xD;
          -  Post-operative predicted Forced Expiratory Volume at one second ≥ 0.8 l&#xD;
&#xD;
          -  Hg ≥ 8.0&#xD;
&#xD;
          -  No evidence of coronary ischemia on stress evaluation Ability to understand and the&#xD;
             willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with surgery for a prior ipsilateral lung cancer&#xD;
&#xD;
        Patients with known brain metastases&#xD;
&#xD;
        Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
        infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
        arrhythmia, or psychiatric illness/social situations that would limit compliance with study&#xD;
        requirements. (Patients with HIV are not excluded from this study)&#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>Joel Thompson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky, Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>June 28, 2018</results_first_submitted>
  <results_first_submitted_qc>October 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 7, 2018</results_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Joel Thompson, PhD</investigator_full_name>
    <investigator_title>Compliance Administrator</investigator_title>
  </responsible_party>
  <keyword>Lung</keyword>
  <keyword>Cancer</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Staging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <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>November 7, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02218242/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ultrasound</title>
          <description>Intraoperative ultrasound&#xD;
Intraoperative ultrasound: Intraoperative ultrasound</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </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>Ultrasound</title>
          <description>Intraoperative ultrasound&#xD;
Intraoperative ultrasound: Intraoperative ultrasound</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age information was collected at the time of consenting</description>
          <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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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="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="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Detection of Occult Pathologic N2 Lymph Nodes</title>
        <description>Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.</description>
        <time_frame>At time of surgery</time_frame>
        <population>An insufficient number of participants were consented to generate meaningful data for this study. We reached an enrollment of less than 10% of what our power calculations suggested we needed. No pathologic lymph nodes were identified, thus the percent of pathologic lymph nodes is in fact zero</population>
        <group_list>
          <group group_id="O1">
            <title>Ultrasound</title>
            <description>Intraoperative ultrasound&#xD;
Intraoperative ultrasound: Intraoperative ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Detection of Occult Pathologic N2 Lymph Nodes</title>
          <description>Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.</description>
          <population>An insufficient number of participants were consented to generate meaningful data for this study. We reached an enrollment of less than 10% of what our power calculations suggested we needed. No pathologic lymph nodes were identified, thus the percent of pathologic lymph nodes is in fact zero</population>
          <units>percentage of pathologic lymph nodes</units>
          <param>Number</param>
          <units_analyzed>lymph nodes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected in the operating room at the time of the procedure. Typically less that 30 minutes.</time_frame>
      <desc>Patients were assessed for adverse events through investigator assessment at the time of the procedure</desc>
      <group_list>
        <group group_id="E1">
          <title>Ultrasound</title>
          <description>Intraoperative ultrasound&#xD;
Intraoperative ultrasound: Intraoperative ultrasound</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="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </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>
    <limitations_and_caveats>The University of Kentucky Medical Center did not treat a sufficient patient population to enroll and complete this study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Angela Mahan</name_or_title>
      <organization>University of Kentucky</organization>
      <phone>859 257 4488</phone>
      <email>angela.mahan@uky.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/NCT02218242
org study id: 13-LUN-95-MCC
nct id: NCT02218242
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will
      receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph
      node dissection. After completion of the standard of care, intraoperative ultrasound will be
      used to evaluate lymph node stations for the presence of any missed lymph nodes with
      particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data
      will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of
      ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is
      hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted
      thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes
      in non-small cell lung cancer patients undergoing definitive surgical resection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Detection of Occult Pathologic N2 Lymph Nodes
time frame: At time of surgery
description: Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.
arm group label: Ultrasound
arm group type: Experimental
description: Participants in this study have elected to have surgical resection of non-small cell lung cancer tumors as part of their standard of care. During that surgical procedure, participants will also receive laparoscopic intraoperative ultrasound to assess the thoracic wall lymph nodes as part of the experimental procedure. The ultrasound procedure will add about 15 minutes to the total surgical time. Because it is laparoscopic and utilizes non-ionizing radiation, the risk to the participant is minimal.
intervention type: Device
intervention name: Intraoperative ultrasound
description: Intraoperative ultrasound will be performed at the completion of the standard lung cancer resection with mediastinal lymph node dissection. This evaluation will be performed by a different surgeon from the primary surgeon performing the operation to minimize operator variability with the ultrasound system and help control for bias. Additional lymph nodes identified will be resected and sent for pathologic evaluation. It is anticipated that this additional evaluation and treatment should take no more than 30 minutes and as such a time limit of 30 minutes from introduction of the ultrasound probe into the surgical field will be set.
arm group label: Ultrasound
other name: B-K Medical/Analogic 8666-Radio Frequency laparoscopic ultrasound transducer and the bedside flex Focus 1202 imaging system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel Thompson, PhD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Joel Thompson, PhD
investigator title: Compliance Administrator
mesh term: Lung Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The University of Kentucky Medical Center did not treat a sufficient patient population to enroll and complete this study.
point of contact: 