<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/NCT01668914</url>
  </required_header>
  <id_info>
    <org_study_id>IMSN002</org_study_id>
    <nct_id>NCT01668914</nct_id>
  </id_info>
  <brief_title>Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive</brief_title>
  <acronym>IMSLNB-CANP</acronym>
  <official_title>Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong Cancer Hospital and Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is&#xD;
      another important lymphatic channel of the breast. The status of IMLNs also provides&#xD;
      important prognostic information for breast cancer patients. The technical evolvements of&#xD;
      sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for&#xD;
      assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was&#xD;
      performed in the patients with clinically negative axillary nodes. However, previous&#xD;
      published studies concerning patients with breast cancer who all underwent a radical&#xD;
      mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary&#xD;
      metastases. For this reason, IM-SLNB is even more important for clinically axillary&#xD;
      node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early&#xD;
      breast cancer patients with clinically positive axillary nodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
        -  Determine the impact of routinely performed internal mammary sentinel lymph node biopsy&#xD;
           on the systemic and locoregional treatments plan.&#xD;
&#xD;
        -  Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with&#xD;
           clinically axillary node-positive.&#xD;
&#xD;
        -  Draw the learning curve of internal mammary sentinel lymph node biopsy.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur&#xD;
      colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2&#xD;
      quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before&#xD;
      surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the&#xD;
      internal mammary sentinel lymph nodes were sent to histologic examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>Phase 3</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visualization Rate of IMSLNs</measure>
    <time_frame>1 year</time_frame>
    <description>visualization rate of internal mammary hotspots in lymphoscintigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis Rate of IMSLNs</measure>
    <time_frame>1 year</time_frame>
    <description>Metastasis Rate of internal mammary sentinel lymph node</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>clinically positive axillary nodes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IM-SLNB</intervention_name>
    <description>IM-SLNB is performed according to the pre-operative lymphoscintigraphy</description>
    <arm_group_label>clinically positive axillary nodes</arm_group_label>
    <other_name>Internal Mammary Sentinel Lymph Node Biopsy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>99mTc-SC</intervention_name>
    <description>Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.</description>
    <arm_group_label>clinically positive axillary nodes</arm_group_label>
    <other_name>99mTc-labeled Sulfur Colloid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Histologic Examination</intervention_name>
    <description>All IMSLNs were analyzed by histologic examination for future therapy planning.</description>
    <arm_group_label>clinically positive axillary nodes</arm_group_label>
    <other_name>hematoxylin-eosin staining and immunohistochemistry</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LSG</intervention_name>
    <description>lymphoscintigraphy was performed 0.5~1.0 hour before surgery</description>
    <arm_group_label>clinically positive axillary nodes</arm_group_label>
    <other_name>Lymphoscintigraphy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylthioninium</intervention_name>
    <description>Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery</description>
    <arm_group_label>clinically positive axillary nodes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary breast cancer&#xD;
&#xD;
          -  clinically axilla-positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  enlarged internal mammary nodes by imaging&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong-sheng Wang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peng-fei Qiu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yan-bing Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shandong Cancer Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
    <investigator_full_name>Yongsheng Wang</investigator_full_name>
    <investigator_title>Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Clinically Axillary Node -Positive</keyword>
  <keyword>Sentinel Lymph Node Biopsy</keyword>
  <keyword>Internal Mammary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01668914
org study id: IMSN002
nct id: NCT01668914
lead sponsor: 
has dmc: No
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is
      another important lymphatic channel of the breast. The status of IMLNs also provides
      important prognostic information for breast cancer patients. The technical evolvements of
      sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for
      assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was
      performed in the patients with clinically negative axillary nodes. However, previous
      published studies concerning patients with breast cancer who all underwent a radical
      mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary
      metastases. For this reason, IM-SLNB is even more important for clinically axillary
      node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early
      breast cancer patients with clinically positive axillary nodes.
OBJECTIVES:

        -  Determine the impact of routinely performed internal mammary sentinel lymph node biopsy
           on the systemic and locoregional treatments plan.

        -  Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with
           clinically axillary node-positive.

        -  Draw the learning curve of internal mammary sentinel lymph node biopsy.

      OUTLINE:

      3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur
      colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2
      quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before
      surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the
      internal mammary sentinel lymph nodes were sent to histologic examination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
time frame: 1 year
description: Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
measure: Visualization Rate of IMSLNs
time frame: 1 year
description: visualization rate of internal mammary hotspots in lymphoscintigraphy
measure: Metastasis Rate of IMSLNs
time frame: 1 year
description: Metastasis Rate of internal mammary sentinel lymph node
arm group label: clinically positive axillary nodes
arm group type: Experimental
description: 3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination
intervention type: Procedure
intervention name: IM-SLNB
description: IM-SLNB is performed according to the pre-operative lymphoscintigraphy
arm group label: clinically positive axillary nodes
other name: Internal Mammary Sentinel Lymph Node Biopsy
intervention type: Radiation
intervention name: 99mTc-SC
description: Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.
arm group label: clinically positive axillary nodes
other name: 99mTc-labeled Sulfur Colloid
intervention type: Device
intervention name: Histologic Examination
description: All IMSLNs were analyzed by histologic examination for future therapy planning.
arm group label: clinically positive axillary nodes
other name: hematoxylin-eosin staining and immunohistochemistry
intervention type: Device
intervention name: LSG
description: lymphoscintigraphy was performed 0.5~1.0 hour before surgery
arm group label: clinically positive axillary nodes
other name: Lymphoscintigraphy
intervention type: Drug
intervention name: Methylthioninium
description: Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
arm group label: clinically positive axillary nodes
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yong-sheng Wang, MD
role: Study Chair
affiliation: Shandong Cancer Hospital and Institute
last name: Peng-fei Qiu, MD
role: Principal Investigator
affiliation: Shandong Cancer Hospital and Institute
last name: Yan-bing Liu, MD
role: Principal Investigator
affiliation: Shandong Cancer Hospital and Institute
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong Cancer Hospital and Institute
investigator full name: Yongsheng Wang
investigator title: Director, Head of Breast Cancer Center, Principal Investigator, Clinical Professor
mesh term: Breast Neoplasms