<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/NCT03038152</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0806</org_study_id>
    <secondary_id>NCI-2017-00649</secondary_id>
    <secondary_id>2016-0806</secondary_id>
    <nct_id>NCT03038152</nct_id>
  </id_info>
  <brief_title>Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery</brief_title>
  <official_title>A Prospective, Open Label Study of the Use of Magseed® and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-Proven Metastases in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This phase IV trial studies the side effects of the Magseed magnetic marker and how well it&#xD;
      works in locating lymph nodes in the underarm area in patients with breast cancer undergoing&#xD;
      surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may&#xD;
      help the surgeon locate the lymph nodes during surgery without using radiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved&#xD;
      in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary&#xD;
      dissection in breast cancer patients.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive the Magseed marker via ultrasound guided injection into the previously&#xD;
      clipped lymph node or within perinodal tissue =&lt; 3 mm from the clipped node. Patients then&#xD;
      undergo axillary lymph node localization and targeted dissection within 30 days.&#xD;
&#xD;
      After completion of study, patients are followed up within 6-22 days post-surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>Phase 4</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>Retrieval rate</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Will be defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects. For the analysis of retrieval rate, if the trial is not stopped early and all 50 patients are accrued, then point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the association of patient demographic and clinical factors with the retrieval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 6 weeks post-procedure</time_frame>
    <description>Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiologist rated ease of Magseed placement</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Descriptive statistics will be used to summarize the radiologist rated ease of Magseed placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of Magseed placement</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon rated ease of node localization and removal</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Descriptive statistics will be used to summarize surgeon rated ease of localization. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nodes retrieved within the surgical specimen containing the Magseed</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcutaneous detection rate</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Descriptive statistics will be used to summarize transcutaneous detection rate. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Breast Carcinoma Metastatic in Lymph Node</condition>
  <condition>Stage II Breast Cancer AJCC v6 and v7</condition>
  <condition>Stage IIA Breast Cancer AJCC v6 and v7</condition>
  <condition>Stage IIB Breast Cancer AJCC v6 and v7</condition>
  <condition>Stage IIIA Breast Cancer AJCC v7</condition>
  <condition>Stage IIIB Breast Cancer AJCC v7</condition>
  <arm_group>
    <arm_group_label>Diagnostic (Magseed marker)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =&lt; 3mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Axillary Lymph Node Dissection</intervention_name>
    <description>Undergo targeted axillary lymph node dissection</description>
    <arm_group_label>Diagnostic (Magseed marker)</arm_group_label>
    <other_name>ALND</other_name>
    <other_name>Axillary Dissection</other_name>
    <other_name>Axillary Lymphadenectomy</other_name>
    <other_name>Axillary Node Dissection</other_name>
    <other_name>Excision Axillary Lymph Nodes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Localization</intervention_name>
    <description>Undergo axillary lymph node localization</description>
    <arm_group_label>Diagnostic (Magseed marker)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medical Device</intervention_name>
    <description>Receive Magseed via ultrasound guided injection</description>
    <arm_group_label>Diagnostic (Magseed marker)</arm_group_label>
    <other_name>Device</other_name>
    <other_name>Medical Devices</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed cT0-4, N1 breast cancer&#xD;
&#xD;
          -  Axillary lymph node metastasis with pathologic confirmation by needle biopsy&#xD;
&#xD;
          -  Clip placed in the sampled axillary lymph node before completing chemotherapy&#xD;
&#xD;
          -  Received neoadjuvant chemotherapy prior to surgical resection&#xD;
&#xD;
          -  Scheduled for targeted axillary dissection (defined as selective localization and&#xD;
             removal of the clipped node and sentinel lymph node dissection [SLND])&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastases&#xD;
&#xD;
          -  Inflammatory breast cancer&#xD;
&#xD;
          -  Prior surgical axillary procedure including SLND or axillary node excision&#xD;
&#xD;
          -  Prior history of breast cancer in the ipsilateral breast&#xD;
&#xD;
          -  History of lymphoma&#xD;
&#xD;
          -  The subject is known to be pregnant. Premenopausal patients under the age of 50 must&#xD;
             have a pregnancy test performed as standard of care before the MagSeed is placed&#xD;
&#xD;
          -  Previous radiation to the breast or axilla&#xD;
&#xD;
          -  Pacemaker of other implantable device in the chest wall&#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>Abigail S Caudle</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</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>Breast Neoplasms</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/NCT03038152
org study id: 2016-0806
secondary id: NCI-2017-00649
secondary id: 2016-0806
nct id: NCT03038152
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase IV trial studies the side effects of the Magseed magnetic marker and how well it
      works in locating lymph nodes in the underarm area in patients with breast cancer undergoing
      surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may
      help the surgeon locate the lymph nodes during surgery without using radiation.
PRIMARY OBJECTIVE:

      I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved
      in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary
      dissection in breast cancer patients.

      OUTLINE:

      Patients receive the Magseed marker via ultrasound guided injection into the previously
      clipped lymph node or within perinodal tissue =< 3 mm from the clipped node. Patients then
      undergo axillary lymph node localization and targeted dissection within 30 days.

      After completion of study, patients are followed up within 6-22 days post-surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Retrieval rate
time frame: Up to 15 months
description: Will be defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects. For the analysis of retrieval rate, if the trial is not stopped early and all 50 patients are accrued, then point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the association of patient demographic and clinical factors with the retrieval.
measure: Incidence of adverse events
time frame: Up to 6 weeks post-procedure
description: Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
measure: Radiologist rated ease of Magseed placement
time frame: Up to 15 months
description: Descriptive statistics will be used to summarize the radiologist rated ease of Magseed placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.
measure: Accuracy of Magseed placement
time frame: Up to 15 months
description: Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.
measure: Surgeon rated ease of node localization and removal
time frame: Up to 15 months
description: Descriptive statistics will be used to summarize surgeon rated ease of localization. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.
measure: Number of nodes retrieved within the surgical specimen containing the Magseed
time frame: Up to 15 months
description: Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.
measure: Transcutaneous detection rate
time frame: Up to 15 months
description: Descriptive statistics will be used to summarize transcutaneous detection rate. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.
arm group label: Diagnostic (Magseed marker)
arm group type: Experimental
description: Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =< 3mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.
intervention type: Procedure
intervention name: Axillary Lymph Node Dissection
description: Undergo targeted axillary lymph node dissection
arm group label: Diagnostic (Magseed marker)
other name: ALND
other name: Axillary Dissection
other name: Axillary Lymphadenectomy
other name: Axillary Node Dissection
other name: Excision Axillary Lymph Nodes
intervention type: Procedure
intervention name: Localization
description: Undergo axillary lymph node localization
arm group label: Diagnostic (Magseed marker)
intervention type: Device
intervention name: Medical Device
description: Receive Magseed via ultrasound guided injection
arm group label: Diagnostic (Magseed marker)
other name: Device
other name: Medical Devices
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abigail S Caudle
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Breast Neoplasms