<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/NCT02994225</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01623-48</org_study_id>
    <secondary_id>2016/2462</secondary_id>
    <nct_id>NCT02994225</nct_id>
  </id_info>
  <brief_title>Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity</brief_title>
  <acronym>ARMONIC</acronym>
  <official_title>Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</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>
      The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes&#xD;
      is of paramount importance in the subsequent management of this cancer and surgery of&#xD;
      invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm&#xD;
      lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic&#xD;
      drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is&#xD;
      uncertain.&#xD;
&#xD;
      The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of&#xD;
      draining lymphatics. The project aims to train surgeons to the technique and to identify&#xD;
      predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary&#xD;
      pathological parameters to better select patients who would not require removal of the ARM&#xD;
      node in the future&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">August 5, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</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>Rate of identification</measure>
    <time_frame>up to 30 days</time_frame>
    <description>To determine the Rate of identification of reverse axillary node using Indocyanine green (ICG) and near-infrared (NIR) imaging in invasive breast cancer that undergo total mastectomy and ALND.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.&#xD;
Near Infra-red images acquisition is performed during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indocyanine Green</intervention_name>
    <description>Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.&#xD;
Near Infra-red images acquisition is performed during surgery</description>
    <arm_group_label>Study arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over 18 years of age&#xD;
&#xD;
          -  Preoperative diagnosis of Invasive breast cancer&#xD;
&#xD;
          -  Patient deemed for total mastectomy with axillary lymph node dissection (ALND)&#xD;
&#xD;
          -  Subject capable of giving informed consent and participating in the process of consent&#xD;
&#xD;
          -  Affiliated to the french social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mastectomy without ALND&#xD;
&#xD;
          -  Previous ipsilateral axillary radiotherapy&#xD;
&#xD;
          -  Previous axillary surgery&#xD;
&#xD;
          -  Pregnant women as determined by urinary or serum beta human chorionic gonadotropin&#xD;
             (hCG) within 72 hours of surgery&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Allergy to indocyanine green&#xD;
&#xD;
          -  Patients with a known history of reaction to iodine or iodine-containing compounds.&#xD;
&#xD;
          -  No consent&#xD;
&#xD;
          -  Impaired capacity to make informed medical decisions&#xD;
&#xD;
          -  Patient on guardianship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chafika MAZOUNI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val De Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 11, 2022</last_update_submitted>
  <last_update_submitted_qc>May 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2022</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/NCT02994225
org study id: 2016-A01623-48
secondary id: 2016/2462
nct id: NCT02994225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes
      is of paramount importance in the subsequent management of this cancer and surgery of
      invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm
      lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic
      drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is
      uncertain.

      The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of
      draining lymphatics. The project aims to train surgeons to the technique and to identify
      predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary
      pathological parameters to better select patients who would not require removal of the ARM
      node in the future
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of identification
time frame: up to 30 days
description: To determine the Rate of identification of reverse axillary node using Indocyanine green (ICG) and near-infrared (NIR) imaging in invasive breast cancer that undergo total mastectomy and ALND.
arm group label: Study arm
arm group type: Experimental
description: Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
intervention type: Drug
intervention name: Indocyanine Green
description: Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
arm group label: Study arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chafika MAZOUNI, MD
role: Principal Investigator
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No