<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/NCT03796559</url>
  </required_header>
  <id_info>
    <org_study_id>US-003</org_study_id>
    <nct_id>NCT03796559</nct_id>
  </id_info>
  <brief_title>Magseed Enabled Long-Term Localization of Axillary Lymph Nodes</brief_title>
  <acronym>MAGELLAN</acronym>
  <official_title>A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endomagnetics Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Endomagnetics Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag&#xD;
      in marking axillary lymph nodes and guiding surgical localization in patients with breast&#xD;
      cancer following neo-adjuvant chemotherapy (NAC) is effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in&#xD;
      patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed&#xD;
      to mark the metastatic node and are having that clipped node selectively removed at surgery&#xD;
      following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark&#xD;
      axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before&#xD;
      initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag&#xD;
      system during surgery and removed with the targeted lymph node.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 13, 2019</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Retrieval rate of clipped node and Magseed in the excised specimen</measure>
    <time_frame>Time of surgery</time_frame>
    <description>The retrieval rate of the clipped node and Magseed in the excised specimen. This is 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of device and serious device-related events</measure>
    <time_frame>Up to 42 days post-surgery</time_frame>
    <description>Rates of device-related adverse events and serious device-related adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiologic rated ease of Magseed placement</measure>
    <time_frame>Time of Magseed marker placement</time_frame>
    <description>5 point Likert scale, very easy = 5, very difficult = 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiologic placement accuracy</measure>
    <time_frame>Between completion of NAC time of surgery</time_frame>
    <description>Success rate of seed placement (placement accuracy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiologic seed position</measure>
    <time_frame>After completion of NAC</time_frame>
    <description>Success rate of maintained seed position at the completion of NAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical nodes localized</measure>
    <time_frame>Time of surgery</time_frame>
    <description>Number of nodes retrieved within the surgical specimen containing the Magseed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of surgical localization</measure>
    <time_frame>Time of surgery</time_frame>
    <description>5 point Likert scalevery easy = 5, very difficult = 1</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Axillary Lymph Nodes</condition>
  <arm_group>
    <arm_group_label>Magseed marker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magseed Marker</intervention_name>
    <description>Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.</description>
    <arm_group_label>Magseed marker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older at time of consent&#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 initiation of chemotherapy&#xD;
&#xD;
          -  Planned for neo-adjuvant chemotherapy prior to surgical resection&#xD;
&#xD;
          -  Eligible for targeted axillary dissection (defined as selective localization and&#xD;
             removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastases&#xD;
&#xD;
          -  Inflammatory breast cancer&#xD;
&#xD;
          -  Prior ipsilateral axillary surgical 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;
          -  Subject is pregnant&#xD;
&#xD;
          -  Previous radiation to the breast or axilla&#xD;
&#xD;
          -  Pacemaker or other implantable cardiac device in the ipsilateral 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 Caudle, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD Anderson Cancer Center, Houston, TX</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matt Womack, PhD</last_name>
    <phone>+447851247439</phone>
    <email>mwomack@endomag.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Baylor Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivan Marin</last_name>
      <email>ivan.marin@bcm.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Veronika Noregil</last_name>
      <email>VYNovegil@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Kelly Hunt, MD, F.A.C.S.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neo-adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03796559
org study id: US-003
nct id: NCT03796559
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag
      in marking axillary lymph nodes and guiding surgical localization in patients with breast
      cancer following neo-adjuvant chemotherapy (NAC) is effective.
This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in
      patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed
      to mark the metastatic node and are having that clipped node selectively removed at surgery
      following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark
      axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before
      initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag
      system during surgery and removed with the targeted lymph node.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Retrieval rate of clipped node and Magseed in the excised specimen
time frame: Time of surgery
description: The retrieval rate of the clipped node and Magseed in the excised specimen. This is 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.
measure: Rates of device and serious device-related events
time frame: Up to 42 days post-surgery
description: Rates of device-related adverse events and serious device-related adverse events
measure: Radiologic rated ease of Magseed placement
time frame: Time of Magseed marker placement
description: 5 point Likert scale, very easy = 5, very difficult = 1
measure: Radiologic placement accuracy
time frame: Between completion of NAC time of surgery
description: Success rate of seed placement (placement accuracy)
measure: Radiologic seed position
time frame: After completion of NAC
description: Success rate of maintained seed position at the completion of NAC
measure: Surgical nodes localized
time frame: Time of surgery
description: Number of nodes retrieved within the surgical specimen containing the Magseed
measure: Ease of surgical localization
time frame: Time of surgery
description: 5 point Likert scalevery easy = 5, very difficult = 1
arm group label: Magseed marker
arm group type: Experimental
description: Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.
intervention type: Device
intervention name: Magseed Marker
description: Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
arm group label: Magseed marker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abigail Caudle, MD, MS
role: Principal Investigator
affiliation: MD Anderson Cancer Center, Houston, TX
last name: Matt Womack, PhD
phone: +447851247439
email: mwomack@endomag.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No