<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/NCT03281720</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1622</org_study_id>
    <secondary_id>16-1583</secondary_id>
    <nct_id>NCT03281720</nct_id>
  </id_info>
  <brief_title>Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases</brief_title>
  <acronym>TAD</acronym>
  <official_title>Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine how feasible and accurate identifying and&#xD;
      removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is&#xD;
      when patients present with breast cancer that has spread to lymph nodes in the axilla. The&#xD;
      specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves&#xD;
      that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for&#xD;
      future removal. That lymph node will be removed after systemic therapy and compared with the&#xD;
      rest of the lymph nodes removed from that region.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2017</start_date>
  <completion_date type="Actual">May 24, 2021</completion_date>
  <primary_completion_date type="Actual">March 4, 2021</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>The false negative rate of TAD</measure>
    <time_frame>two years</time_frame>
    <description>will be defined as the percentage of patients in whom the lymph nodes identified with TAD were free of residual metastatic disease while remaining metastatic disease was demonstrated in the completion axillary lymph node dissection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nodal pathologic complete response</measure>
    <time_frame>two years</time_frame>
    <description>will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of lymph nodes removed with ALND not identified by TAD that harbor residual metastasis</measure>
    <time_frame>two years</time_frame>
    <description>will be calculated by the formula: (# pos LN/# LN sampled by ALND) x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The success rate of preoperative localization with the Savi Scout®</measure>
    <time_frame>two years</time_frame>
    <description>will be determined by the number of reflectors placed versus the number of reflectors detected at the time of surgery.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Targeted Axillary Dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After patients have completed their neoadjuvant systemic therapy, they will have a Savi Scout® electromagnetic reflector placed into the clipped axillary lymph nodes.&#xD;
The surgeon will then use the Savi Scout detector intraoperatively to identify and remove your clipped lymph nodes prior to removing the remainder of the axillary lymph nodes in a surgery called an &quot;axillary dissection&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAD</intervention_name>
    <description>the same intervention as listed in the arm description</description>
    <arm_group_label>Targeted Axillary Dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1-3 (maximum&#xD;
             three abnormal axillary nodes on ultrasound exam) M0.&#xD;
&#xD;
          2. Core needle biopsy (or fine needle aspiration (FNA)) of an axillary node documenting&#xD;
             nodal disease at time of diagnosis and prior to preoperative systemic therapy or&#xD;
             surgery. Clinical care marker clip placed in the abnormal axillary nodes identified at&#xD;
             ultrasound at the time of core needle or FNA of an axillary node that documented nodal&#xD;
             disease.&#xD;
&#xD;
          3. Subjects must be undergoing neoadjuvant systemic therapy (or have just completed it)&#xD;
             prior to the surgical intervention.&#xD;
&#xD;
          4. No prior axillary lymph node surgery for pathological confirmation of axillary status.&#xD;
&#xD;
          5. No nitinol (nickel-titanium) allergy. The Savi Scout ® marker device contains nitinol.&#xD;
&#xD;
          6. Females of childbearing potential must have a negative serum pregnancy test within 14&#xD;
             days prior to receipt of chemotherapy. NOTE: Females are considered of child bearing&#xD;
             potential unless they are surgically sterile (have undergone a hysterectomy, bilateral&#xD;
             tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at&#xD;
             least 12 consecutive months&#xD;
&#xD;
          7. Females of childbearing potential must be willing to abstain from heterosexual&#xD;
             activity or to use 2 forms of effective methods of contraception from the time of&#xD;
             informed consent until 30 days after chemotherapy discontinuation. The two&#xD;
             contraception methods can be comprised of two barrier methods, or a barrier method&#xD;
             plus a hormonal method or an intrauterine device that meets &lt;1% failure rate for&#xD;
             protection from pregnancy in the product label.&#xD;
&#xD;
          8. As determined by the enrolling physician or protocol designee, ability of the subject&#xD;
             to understand and comply with study procedures for the entire length of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active infection requiring systemic therapy&#xD;
&#xD;
          2. Has a known additional malignancy that is active and/or progressive requiring&#xD;
             treatment; exceptions include basal cell or squamous cell skin cancer, in situ&#xD;
             cervical or bladder cancer.&#xD;
&#xD;
          3. Any distant metastasis by imaging and biopsy (cM1)&#xD;
&#xD;
          4. Patients not receiving neoadjuvant systemic therapy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UNC- Chapel Hill Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphatic Metastasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03281720
org study id: LCCC1622
secondary id: 16-1583
nct id: NCT03281720
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to determine how feasible and accurate identifying and
      removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is
      when patients present with breast cancer that has spread to lymph nodes in the axilla. The
      specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves
      that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for
      future removal. That lymph node will be removed after systemic therapy and compared with the
      rest of the lymph nodes removed from that region.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The false negative rate of TAD
time frame: two years
description: will be defined as the percentage of patients in whom the lymph nodes identified with TAD were free of residual metastatic disease while remaining metastatic disease was demonstrated in the completion axillary lymph node dissection
measure: Nodal pathologic complete response
time frame: two years
description: will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND.
measure: The percentage of lymph nodes removed with ALND not identified by TAD that harbor residual metastasis
time frame: two years
description: will be calculated by the formula: (# pos LN/# LN sampled by ALND) x 100
measure: The success rate of preoperative localization with the Savi Scout®
time frame: two years
description: will be determined by the number of reflectors placed versus the number of reflectors detected at the time of surgery.
arm group label: Targeted Axillary Dissection
arm group type: Experimental
description: After patients have completed their neoadjuvant systemic therapy, they will have a Savi Scout® electromagnetic reflector placed into the clipped axillary lymph nodes.
The surgeon will then use the Savi Scout detector intraoperatively to identify and remove your clipped lymph nodes prior to removing the remainder of the axillary lymph nodes in a surgery called an "axillary dissection".
intervention type: Procedure
intervention name: TAD
description: the same intervention as listed in the arm description
arm group label: Targeted Axillary Dissection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphatic Metastasis