<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/NCT04438577</url>
  </required_header>
  <id_info>
    <org_study_id>ShantouCH</org_study_id>
    <nct_id>NCT04438577</nct_id>
  </id_info>
  <brief_title>Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery</brief_title>
  <acronym>LI-CTD</acronym>
  <official_title>Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shantou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shantou Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast&#xD;
      carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins&#xD;
      at final histopathology. Currently available modalities used for intraoperative surgical&#xD;
      margin assessment all have specific limitations. In order to improve intraoperative tumor&#xD;
      localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the&#xD;
      Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent&#xD;
      camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine&#xD;
      mucilage-ICG as an agent for intraoperative tumor delineation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>Margin width</measure>
    <time_frame>7 days</time_frame>
    <description>The distance between tumor and margin on the gross specimen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive margin rate</measure>
    <time_frame>7 days</time_frame>
    <description>The percentage of patients with a positive margin out of the participants</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Efficacy of Lidocaine mucilage-ICG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine mucilage-ICG</intervention_name>
    <description>Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation</description>
    <arm_group_label>Efficacy of Lidocaine mucilage-ICG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female at least 18 years old&#xD;
&#xD;
          -  Histologically or cytologically confirmed breast carcinoma&#xD;
&#xD;
          -  Patients planned to receive a breast-conserving surgery&#xD;
&#xD;
          -  Patients received a preoperative breast magnetic resonance imaging&#xD;
&#xD;
          -  Informed consent form understood and signed&#xD;
&#xD;
          -  Patient agrees to all follow-up visits&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of&#xD;
             study entry&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test performed&#xD;
             within 7 days prior to the surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or other condition that may interfere with the study&#xD;
&#xD;
          -  Known allergy or contraindication to any study drug&#xD;
&#xD;
          -  Patients received neoadjuvant therapies&#xD;
&#xD;
          -  Patients received an excision biopsy of the tumor&#xD;
&#xD;
          -  Breast feeding period&#xD;
&#xD;
          -  Pregnant (female of childbearing potential only)&#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>Si-Qi Qiu, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shantou Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mian-Han Zhuang</last_name>
    <phone>008613750445342</phone>
    <email>jgbst@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shantou Central Hospital</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <zip>515300</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Si-Qi Qiu, Dr.</last_name>
      <phone>008613790868950</phone>
      <email>s_patrick@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shantou Central Hospital</investigator_affiliation>
    <investigator_full_name>Si-Qi Qiu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast conserving surgery; fluorescence-guided surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_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/NCT04438577
org study id: ShantouCH
nct id: NCT04438577
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast
      carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins
      at final histopathology. Currently available modalities used for intraoperative surgical
      margin assessment all have specific limitations. In order to improve intraoperative tumor
      localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the
      Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent
      camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine
      mucilage-ICG as an agent for intraoperative tumor delineation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Margin width
time frame: 7 days
description: The distance between tumor and margin on the gross specimen
measure: Positive margin rate
time frame: 7 days
description: The percentage of patients with a positive margin out of the participants
arm group label: Efficacy of Lidocaine mucilage-ICG
arm group type: Experimental
description: Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation
intervention type: Drug
intervention name: Lidocaine mucilage-ICG
description: Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation
arm group label: Efficacy of Lidocaine mucilage-ICG
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Si-Qi Qiu, Dr.
role: Principal Investigator
affiliation: Shantou Central Hospital
last name: Mian-Han Zhuang
phone: 008613750445342
email: jgbst@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shantou Central Hospital
investigator full name: Si-Qi Qiu
investigator title: Principal Investigator
mesh term: Lidocaine
sharing ipd: No