<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/NCT04487912</url>
  </required_header>
  <id_info>
    <org_study_id>AGO/2019/003</org_study_id>
    <nct_id>NCT04487912</nct_id>
  </id_info>
  <brief_title>Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer</brief_title>
  <official_title>Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norgine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A sentinel node procedure is recommended for patients with early stages of breast cancer to&#xD;
      exclude metastases to local lymph nodes. This procedure is done with a &quot;tracer&quot; which is&#xD;
      injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph&#xD;
      node(s) are called &quot;sentinel&quot; node(s). These sentinel nodes are excised by the surgeon for&#xD;
      microscopic investigation using a detection probe. This study aims to further document the&#xD;
      distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing&#xD;
      it with the standard used tracer (nanocolloid) to determine whether there is a significant&#xD;
      difference between both products (which are both approved for clinical use in this scenario&#xD;
      in the European Union). This will be done by randomly assigning patients between injection of&#xD;
      Tilmanocept or Nanocolloid and making scans on multiple (3) time points.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Insufficient patient inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">November 24, 2020</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to identification of first lymph node</measure>
    <time_frame>0-30 minutes</time_frame>
    <description>Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymph node count to background ratio 4 hours post-injection</measure>
    <time_frame>4 hours post-injection</time_frame>
    <description>Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymph node count to background ratio 24 hours post-injection</measure>
    <time_frame>20 to 24 hours post-injection</time_frame>
    <description>Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Injection site count to background ratio 4 hours post-injection</measure>
    <time_frame>4 hours post-injection</time_frame>
    <description>Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Injection site count to background ratio 24 hours post-injection</measure>
    <time_frame>20 to 24 hours post-injection</time_frame>
    <description>Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Sentinel Lymph Node</condition>
  <arm_group>
    <arm_group_label>Injection of 99m-Tc Tilmanocept</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Injection of 99m-Tc Nanocolloid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tilmanocept</intervention_name>
    <description>Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept</description>
    <arm_group_label>Injection of 99m-Tc Tilmanocept</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nanocolloid</intervention_name>
    <description>Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid</description>
    <arm_group_label>Injection of 99m-Tc Nanocolloid</arm_group_label>
    <other_name>Nanoscint</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early stage breast cancer (T1, T2)&#xD;
&#xD;
          -  Clinically node negative (no enlarged axillary lymph nodes)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior surgery in same breast&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>university hospital, Ghent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Giammarile F, Alazraki N, Aarsvold JN, Audisio RA, Glass E, Grant SF, Kunikowska J, Leidenius M, Moncayo VM, Uren RF, Oyen WJ, Valdes Olmos RA, Vidal Sicart S. The EANM and SNMMI practice guideline for lymphoscintigraphy and sentinel node localization in breast cancer. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1932-47. doi: 10.1007/s00259-013-2544-2. Epub 2013 Oct 2.</citation>
    <PMID>24085499</PMID>
  </reference>
  <reference>
    <citation>Unkart JT, Hosseini A, Wallace AM. Tc-99m tilmanocept versus Tc-99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial. J Surg Oncol. 2017 Dec;116(7):819-823. doi: 10.1002/jso.24735. Epub 2017 Jul 10.</citation>
    <PMID>28695567</PMID>
  </reference>
  <reference>
    <citation>Unkart JT, Proudfoot J, Wallace AM. Outcomes of &quot;one-day&quot; vs &quot;two-day&quot; injection protocols using Tc-99m tilmanocept for sentinel lymph node biopsy in breast cancer. Breast J. 2018 Jul;24(4):526-530. doi: 10.1111/tbj.13002. Epub 2018 Mar 2.</citation>
    <PMID>29498443</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 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>
  <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/NCT04487912
org study id: AGO/2019/003
nct id: NCT04487912
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
A sentinel node procedure is recommended for patients with early stages of breast cancer to
      exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is
      injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph
      node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for
      microscopic investigation using a detection probe. This study aims to further document the
      distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing
      it with the standard used tracer (nanocolloid) to determine whether there is a significant
      difference between both products (which are both approved for clinical use in this scenario
      in the European Union). This will be done by randomly assigning patients between injection of
      Tilmanocept or Nanocolloid and making scans on multiple (3) time points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
measure: Time to identification of first lymph node
time frame: 0-30 minutes
description: Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
measure: Lymph node count to background ratio 4 hours post-injection
time frame: 4 hours post-injection
description: Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection
measure: Lymph node count to background ratio 24 hours post-injection
time frame: 20 to 24 hours post-injection
description: Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection
measure: Injection site count to background ratio 4 hours post-injection
time frame: 4 hours post-injection
description: Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection
measure: Injection site count to background ratio 24 hours post-injection
time frame: 20 to 24 hours post-injection
description: Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection
arm group label: Injection of 99m-Tc Tilmanocept
arm group type: Active Comparator
arm group label: Injection of 99m-Tc Nanocolloid
arm group type: Active Comparator
intervention type: Drug
intervention name: Tilmanocept
description: Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
arm group label: Injection of 99m-Tc Tilmanocept
intervention type: Drug
intervention name: Nanocolloid
description: Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid
arm group label: Injection of 99m-Tc Nanocolloid
other name: Nanoscint
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
citation: Giammarile F, Alazraki N, Aarsvold JN, Audisio RA, Glass E, Grant SF, Kunikowska J, Leidenius M, Moncayo VM, Uren RF, Oyen WJ, Valdes Olmos RA, Vidal Sicart S. The EANM and SNMMI practice guideline for lymphoscintigraphy and sentinel node localization in breast cancer. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1932-47. doi: 10.1007/s00259-013-2544-2. Epub 2013 Oct 2.
PMID: 24085499
citation: Unkart JT, Hosseini A, Wallace AM. Tc-99m tilmanocept versus Tc-99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial. J Surg Oncol. 2017 Dec;116(7):819-823. doi: 10.1002/jso.24735. Epub 2017 Jul 10.
PMID: 28695567
citation: Unkart JT, Proudfoot J, Wallace AM. Outcomes of "one-day" vs "two-day" injection protocols using Tc-99m tilmanocept for sentinel lymph node biopsy in breast cancer. Breast J. 2018 Jul;24(4):526-530. doi: 10.1111/tbj.13002. Epub 2018 Mar 2.
PMID: 29498443
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No