xml: <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/NCT06024213</url>
    </required_header>
    <id_info>
      <org_study_id>PR024-CLN-pro101</org_study_id>
      <nct_id>NCT06024213</nct_id>
    </id_info>
    <brief_title>A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.</brief_title>
    <acronym>OASIS</acronym>
    <official_title>French, Prospective, Post-marketing Study to Describe the Use, Detection Performance and Safety Profile of Infracyanine® (Indocyanine Green) for Breast Cancer Patients Undergoing a Sentinel Lymph Node (SLN) Biopsy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BTG International Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Iqvia Pty Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>BTG International Inc.</source>
    <brief_summary>
      <textblock>
        This prospective, observational study will evaluate the patient-based sentinel lymph node&#xD;
        detection rate when using the Infracyanine® (indocyanine green) dye technique in patients&#xD;
        undergoing surgery for breast cancer.&#xD;
  &#xD;
        The study will describe the demographic, clinical, and tumour characteristics of patients&#xD;
        with breast cancer undergoing surgery.&#xD;
  &#xD;
        The study will describe the characteristics of how the indocyanine green dye technique is&#xD;
        used including the dose and volume of dye used, the number and type of injection sites used&#xD;
        to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and&#xD;
        whether indocyanine green is used on its own or with other dyes (blue dye and/or&#xD;
        99mTechnetium dye).&#xD;
  &#xD;
        The study will evaluate the characteristics of sentinel lymph node biopsy procedures&#xD;
        performed using indocyanine green dye including the number of biopsies performed, the time&#xD;
        taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph&#xD;
        nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.&#xD;
  &#xD;
        The study will also assess the safety of using indocyanine green dye for 6 weeks following&#xD;
        surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 6, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Sentinel lymph node detection rate</measure>
      <time_frame>Time of Surgery</time_frame>
      <description>Rate of detection of at least one sentinel lymph node by indocyanine green</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Patient age</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Patient height</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Patient weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Patient BMI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comorbidities</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Comorbidities of interest</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Menopause status</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Menopause status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prior excisional surgery</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Prior excisional surgery on the breast</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgery type planned</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Type of breast surgery planned</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumour size</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour size</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumour grade</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour grade</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumour stage</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour stage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Histological type</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour histological type</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hormone receptor status</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumour laterality</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour laterality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumour quadrant</measure>
      <time_frame>At visit 1 (pre-operative consultation)</time_frame>
      <description>Tumour quadrant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detection method</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Indocyanine green dose</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Dose of indocyanine green</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Indocyanine green volume</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Volume of indocyanine green</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Injection site</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Description of injection site</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of injection sites</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Number of injection sites</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Route of injection</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Route of injection (periareolar or peritumoural)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Detection equipment</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Equipment used for detection of sentinel lymph node</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of sentinel lymph node biopsies performed</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Number of sentinel lymph node biopsies performed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from injection to visualization</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Time from injection to visualization of first sentinel lymph node</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from injection to end of biopsy</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Time from injection to end of biopsy procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of sentinel lymph nodes detected</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Number of sentinel lymph nodes detected (by all detection methods) per patient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of sentinel lymph nodes detected - indocyanine green</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Number of sentinel lymph nodes detected (by indocyanine green) per patient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of sentinel lymph nodes detected - blue dye</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Number of sentinel lymph nodes detected (by blue dye) per patient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of sentinel lymph nodes detected - 99mTc</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Number of sentinel lymph nodes detected (by 99mTc) per patient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>From time of surgery up to 6 weeks post-surgery</time_frame>
      <description>Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>From time of surgery up to 6 weeks post-surgery</time_frame>
      <description>Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in vital signs</measure>
      <time_frame>From time of surgery up to 6 weeks post-surgery</time_frame>
      <description>Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Sentinel lymph node detection rate by obesity status</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients</description>
    </other_outcome>
    <other_outcome>
      <measure>Sentinel lymph node detection rate in early-stage breast cancer</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer</description>
    </other_outcome>
    <other_outcome>
      <measure>Sentinel lymph node detection rate by indocyanine green dose</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose</description>
    </other_outcome>
    <other_outcome>
      <measure>Sentinel lymph node detection rate by injection route</measure>
      <time_frame>Time of surgery</time_frame>
      <description>Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route</description>
    </other_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Breast Cancer</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Sentinel lymph node identification</intervention_name>
      <description>Intervention description: Intraoperative identification of sentinel lymph node</description>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>indocyanine green</intervention_name>
      <description>Intervention description: indocyanine green (5 to 10 mg [ie, 2 to 4 mL of a 2.5 mg/mL solution]) administered by periareolar or peritumoural route</description>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>methylene blue</intervention_name>
      <description>1%), 2-5 mL administered by periareolar or peritumoural route</description>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Technetium (99mTc)</intervention_name>
      <description>(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will be conducted at French hospitals involved in the management of female&#xD;
          patients with breast cancer where indocyanine green is used in routine practice. Patients&#xD;
          will be enrolled from approximately 5 sites in metropolitan France.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  Aged ≥18 years&#xD;
  &#xD;
            -  Undergoing breast cancer surgery with an indication for sentinel lymph node biopsy&#xD;
  &#xD;
            -  Receiving Infracyanine® (indocyanine green; alone or in combination with blue dye or&#xD;
               99mTc) for intraoperative identification of sentinel lymph node according to the&#xD;
               Summary of Product Characteristics&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Male&#xD;
  &#xD;
            -  Pregnant or nursing female&#xD;
  &#xD;
            -  Previous allergy to indocyanine green or to any excipients&#xD;
  &#xD;
            -  Already included in a surgical trial&#xD;
  &#xD;
            -  Patient opposed to collection and processing of their data&#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>Céline Chauleur, MD</last_name>
      <role>Study Chair</role>
      <affiliation>CHU de Saint-Etienne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jennie Molland</last_name>
      <phone>+44 7805 354 134</phone>
      <email>jennie.molland@serb.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>CH Annecy-Genevois</name>
        <address>
          <city>Annecy</city>
          <state>Epagny Metz-Tessy, Haute-Savoie</state>
          <zip>74370</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Didier Tardif</last_name>
        <phone>+447805354134</phone>
        <email>jennie.molland@serb.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Bergonié</name>
        <address>
          <city>Bordeaux</city>
          <state>Gironde</state>
          <zip>33000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sophie Auriol-Leizagoyen</last_name>
        <phone>+447805354134</phone>
        <email>jennie.molland@serb.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Saint-Etienne</name>
        <address>
          <city>Saint-Etienne</city>
          <state>Loire</state>
          <zip>42100 France</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Institut de Cancérologie de Lorraine</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut de Cancérologie de Lorraine</name>
        <address>
          <city>Vandœuvre-lès-Nancy</city>
          <state>Meurthe-et-Moselle</state>
          <zip>54500</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Frédéric Marchal</last_name>
        <phone>44 7805 354 134</phone>
        <email>jennie.molland@serb.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Lille</name>
        <address>
          <city>Lille</city>
          <state>Nord</state>
          <zip>59000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yohan Kerbage</last_name>
        <phone>44 7805 354 134</phone>
        <email>jennie.molland@serb.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Européen Georges-Pompidou Paris</name>
        <address>
          <city>Paris</city>
          <state>Île-de-France</state>
          <zip>75015</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Meriem Koual</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Vermersch C, Raia-Barjat T, Chapelle C, Lima S, Chauleur C. Randomized comparison between indocyanine green fluorescence plus 99mtechnetium and 99mtechnetium alone methods for sentinel lymph node biopsy in breast cancer. Sci Rep. 2019 May 6;9(1):6943. doi: 10.1038/s41598-019-43473-3.</citation>
      <PMID>31061432</PMID>
    </reference>
    <reference>
      <citation>Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017 Nov 2;15(1):196. doi: 10.1186/s12957-017-1264-7.</citation>
      <PMID>29096643</PMID>
    </reference>
    <reference>
      <citation>Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211.</citation>
      <PMID>16110291</PMID>
    </reference>
    <reference>
      <citation>Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer. Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15.</citation>
      <PMID>26275781</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>sentinel lymph node biopsy</keyword>
    <keyword>indocyanine green biopsy</keyword>
    <keyword>fluorescence blue dye</keyword>
    <keyword>technetium99</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methylene Blue</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024213
  org study id: PR024-CLN-pro101
  nct id: NCT06024213
  lead sponsor: 
  collaborator: 
  This prospective, observational study will evaluate the patient-based sentinel lymph node
        detection rate when using the Infracyanine® (indocyanine green) dye technique in patients
        undergoing surgery for breast cancer.
  
        The study will describe the demographic, clinical, and tumour characteristics of patients
        with breast cancer undergoing surgery.
  
        The study will describe the characteristics of how the indocyanine green dye technique is
        used including the dose and volume of dye used, the number and type of injection sites used
        to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and
        whether indocyanine green is used on its own or with other dyes (blue dye and/or
        99mTechnetium dye).
  
        The study will evaluate the characteristics of sentinel lymph node biopsy procedures
        performed using indocyanine green dye including the number of biopsies performed, the time
        taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph
        nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.
  
        The study will also assess the safety of using indocyanine green dye for 6 weeks following
        surgery.
  observational model: Case-Only
  time perspective: Prospective
  measure: Sentinel lymph node detection rate
  time frame: Time of Surgery
  description: Rate of detection of at least one sentinel lymph node by indocyanine green
  measure: Age
  time frame: At visit 1 (pre-operative consultation)
  description: Patient age
  measure: Height
  time frame: At visit 1 (pre-operative consultation)
  description: Patient height
  measure: Weight
  time frame: At visit 1 (pre-operative consultation)
  description: Patient weight
  measure: BMI
  time frame: At visit 1 (pre-operative consultation)
  description: Patient BMI
  measure: Comorbidities
  time frame: At visit 1 (pre-operative consultation)
  description: Comorbidities of interest
  measure: Menopause status
  time frame: At visit 1 (pre-operative consultation)
  description: Menopause status
  measure: Prior excisional surgery
  time frame: At visit 1 (pre-operative consultation)
  description: Prior excisional surgery on the breast
  measure: Surgery type planned
  time frame: At visit 1 (pre-operative consultation)
  description: Type of breast surgery planned
  measure: Tumour size
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour size
  measure: Tumour grade
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour grade
  measure: Tumour stage
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour stage
  measure: Histological type
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour histological type
  measure: Hormone receptor status
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)
  measure: Tumour laterality
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour laterality
  measure: Tumour quadrant
  time frame: At visit 1 (pre-operative consultation)
  description: Tumour quadrant
  measure: Detection method
  time frame: Time of surgery
  description: Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)
  measure: Indocyanine green dose
  time frame: Time of surgery
  description: Dose of indocyanine green
  measure: Indocyanine green volume
  time frame: Time of surgery
  description: Volume of indocyanine green
  measure: Injection site
  time frame: Time of surgery
  description: Description of injection site
  measure: Number of injection sites
  time frame: Time of surgery
  description: Number of injection sites
  measure: Route of injection
  time frame: Time of surgery
  description: Route of injection (periareolar or peritumoural)
  measure: Detection equipment
  time frame: Time of surgery
  description: Equipment used for detection of sentinel lymph node
  measure: Number of sentinel lymph node biopsies performed
  time frame: Time of surgery
  description: Number of sentinel lymph node biopsies performed
  measure: Time from injection to visualization
  time frame: Time of surgery
  description: Time from injection to visualization of first sentinel lymph node
  measure: Time from injection to end of biopsy
  time frame: Time of surgery
  description: Time from injection to end of biopsy procedure
  measure: Number of sentinel lymph nodes detected
  time frame: Time of surgery
  description: Number of sentinel lymph nodes detected (by all detection methods) per patient
  measure: Number of sentinel lymph nodes detected - indocyanine green
  time frame: Time of surgery
  description: Number of sentinel lymph nodes detected (by indocyanine green) per patient
  measure: Number of sentinel lymph nodes detected - blue dye
  time frame: Time of surgery
  description: Number of sentinel lymph nodes detected (by blue dye) per patient
  measure: Number of sentinel lymph nodes detected - 99mTc
  time frame: Time of surgery
  description: Number of sentinel lymph nodes detected (by 99mTc) per patient
  measure: Adverse events
  time frame: From time of surgery up to 6 weeks post-surgery
  description: Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
  measure: Serious adverse events
  time frame: From time of surgery up to 6 weeks post-surgery
  description: Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA
  measure: Changes in vital signs
  time frame: From time of surgery up to 6 weeks post-surgery
  description: Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate
  measure: Sentinel lymph node detection rate by obesity status
  time frame: Time of surgery
  description: Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients
  measure: Sentinel lymph node detection rate in early-stage breast cancer
  time frame: Time of surgery
  description: Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer
  measure: Sentinel lymph node detection rate by indocyanine green dose
  time frame: Time of surgery
  description: Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose
  measure: Sentinel lymph node detection rate by injection route
  time frame: Time of surgery
  description: Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route
  intervention type: Procedure
  intervention name: Sentinel lymph node identification
  description: Intervention description: Intraoperative identification of sentinel lymph node
  intervention type: Drug
  intervention name: indocyanine green
  description: Intervention description: indocyanine green (5 to 10 mg [ie, 2 to 4 mL of a 2.5 mg/mL solution]) administered by periareolar or peritumoural route
  intervention type: Drug
  intervention name: methylene blue
  description: 1%), 2-5 mL administered by periareolar or peritumoural route
  intervention type: Drug
  intervention name: Technetium (99mTc)
  description: (99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Céline Chauleur, MD
  role: Study Chair
  affiliation: CHU de Saint-Etienne
  last name: Jennie Molland
  phone: +44 7805 354 134
  email: jennie.molland@serb.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: France
  citation: Vermersch C, Raia-Barjat T, Chapelle C, Lima S, Chauleur C. Randomized comparison between indocyanine green fluorescence plus 99mtechnetium and 99mtechnetium alone methods for sentinel lymph node biopsy in breast cancer. Sci Rep. 2019 May 6;9(1):6943. doi: 10.1038/s41598-019-43473-3.
  PMID: 31061432
  citation: Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017 Nov 2;15(1):196. doi: 10.1186/s12957-017-1264-7.
  PMID: 29096643
  citation: Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211.
  PMID: 16110291
  citation: Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer. Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15.
  PMID: 26275781
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Methylene Blue