<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/NCT04482803</url>
  </required_header>
  <id_info>
    <org_study_id>NBC Sur001</org_study_id>
    <nct_id>NCT04482803</nct_id>
  </id_info>
  <brief_title>Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for cN+ Breast Cancer</brief_title>
  <official_title>Feasibility Study of Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node After Neoadjuvant Systemic Therapy for Clinically Assessed Positive Axillary Lymph Node (cN+) Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</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>
      To explore the feasibility of target biopsy of carbon nanoparticles labelled lymph node after&#xD;
      neoadjuvant systemic therapy for cN+ breast cancer, and evaluate whether it can accurately&#xD;
      predict axillary lymph node status after neoadjuvant systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Locally advanced breast cancer patients with clinical assessed positive axillary lymph node&#xD;
      (cN+) who receive neoadjuvant systemic therapy (NST) will be enrolled in this study. Before&#xD;
      NST, one of the suspected lymph nodes will be subjected to ultrasound-guided core needle&#xD;
      biopsy (CNB) or fine needle aspiration (FNA), and a locating clip will be placed. Meanwhile,&#xD;
      a small amount of Kanarine (Carbon Nanoparticles Suspension Injection) will be injected into&#xD;
      or around the cortex of the locating lymph node as well as other positive lymph nodes. All&#xD;
      patients will be confirmed to have axillary lymph node metastasis by pathologic or cytologic&#xD;
      examination. After NST, FNA will be performed again for the lymph nodes labelled with&#xD;
      previous locating clip. During the operation, the clip labelled lymph nodes were identified&#xD;
      with carbon and sent to pathology separately. Meanwhile, the remaining carbon labelled lymph&#xD;
      nodes were also separately examined. Axillary lymph node dissection will be performed in all&#xD;
      patients. The detection rate of labelled lymph node will be record, and the pathological&#xD;
      results of re-FNA of labelled lymph nodes will be compared with postoperative pathological&#xD;
      results. Meanwhile, we will also analysis whether carbon labelled lymph node biopsy could&#xD;
      predict the overall status of axillary lymph nodes after NST.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Actual">May 24, 2023</completion_date>
  <primary_completion_date type="Actual">December 2, 2022</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes</measure>
    <time_frame>1-3 day before NST, the suspected lymph nodes will be injected carbon nanoparticle. During operation, carbon nanoparticle labelled lymph nodes will be identified and sent for examination.</time_frame>
    <description>Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip will be placed, meanwhile, a small amount of carbon nanoparticles suspension injection will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. During operation, carbon nanoparticle labelled lymph nodes will be identified and sent for examination. Then calculate the accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes for postoperative pathology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.</measure>
    <time_frame>1-3 day before NST, one of the cN+ nodes will be placed a locating clip. 1-3 days before surgery, the clip labeled node will be punctured again. During operation, the clip labeled node will be identified and sent for examination.</time_frame>
    <description>Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip will be placed. Before surgery, the clip labeled node will be punctured (FNA) again. During operation, the clip labeled node will be identified and sent for pathological examination. And then calculate the identification rate of labeled lymph nodes and the consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Location and Biopsy of Axillary Lymph Nodes</condition>
  <arm_group>
    <arm_group_label>Carbon nanoparticles labelled lymph nodes group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes before NST.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes</intervention_name>
    <description>Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip (Ultraclip, BARD) will be placed. Meanwhile, a small amount of Kanarine (carbon nanoparticles suspension injection, 0.5ml:25mg, H20073246) will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. Preoperative FNA will be performed again for locating clip labelled node.</description>
    <arm_group_label>Carbon nanoparticles labelled lymph nodes group</arm_group_label>
    <other_name>A locating clip was placed in one of the suspected lymph nodes</other_name>
    <other_name>Preoperative FNA will be performed again for locating clip labelled node</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female breast cancer patients who received neoadjuvant systemic chemotherapy, aged&#xD;
             18-70 years old, with clinically assessed positive lymph node, and the expected&#xD;
             survival period is greater than 12 months.&#xD;
&#xD;
          2. No previous radiotherapy and chemotherapy.&#xD;
&#xD;
          3. No history of serious systemic disease.&#xD;
&#xD;
          4. KPS≥70.&#xD;
&#xD;
          5. White blood cell count&gt; 3.5 × 10 ^ 9 / L, neutrophil count&gt; 1.8 × 10 ^ 9 / L, platelet&#xD;
             count&gt; 100 × 10 ^ 9 / L, hemoglobin&gt; 9 g / dl.&#xD;
&#xD;
          6. ALT and AST &lt;1.5 times the upper limit of normal value, alkaline phosphatase &lt;2.5&#xD;
             times the upper limit of normal value, and total bilirubin &lt;1.5 times the upper limit&#xD;
             of normal value.&#xD;
&#xD;
          7. Serum muscle plasma &lt;1.5 times the upper limit of normal value.&#xD;
&#xD;
          8. No abnormal blood coagulation.&#xD;
&#xD;
          9. Women of childbearing age had a negative serum or urine pregnancy test before the&#xD;
             start of treatment and agreed to contraception during treatment.&#xD;
&#xD;
         10. Cardiac function: two-dimensional echocardiography examination LVEF ≥ 55%.&#xD;
&#xD;
         11. Sign informed consent.&#xD;
&#xD;
        Exclusion critia:&#xD;
&#xD;
          1. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy&#xD;
             and endocrine therapy.&#xD;
&#xD;
          2. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma&#xD;
             and cervical carcinoma in situ).&#xD;
&#xD;
          3. The patient has been enrolled in other clinical trials or used other study drugs 30&#xD;
             days before enrollment in this study.&#xD;
&#xD;
          4. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal&#xD;
             ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue&#xD;
             disease or bone marrow function suppression and other diseases, can not tolerate&#xD;
             chemotherapy related treatments.&#xD;
&#xD;
          5. Two-dimensional echocardiography detection LVEF &lt;55%.&#xD;
&#xD;
          6. Severe cardiovascular and cerebrovascular diseases within the first 6 months of&#xD;
             randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension&gt;&#xD;
             150/90 mmHg, myocardial infarction or cerebrovascular accident).&#xD;
&#xD;
          7. NCI peripheral neurotoxicity grade ≥2.&#xD;
&#xD;
          8. Those taking glucocorticoids.&#xD;
&#xD;
          9. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab or&#xD;
             pertuzumab.&#xD;
&#xD;
         10. Refuse contraception during treatment and within 8 weeks after completion of treatment&#xD;
             for women of childbearing age.&#xD;
&#xD;
         11. Pregnant and lactating women.&#xD;
&#xD;
         12. After joining the test, a pregnancy test (+) before using the drug.&#xD;
&#xD;
         13. There are mental illness, cognitive impairment, unable to understand the test plan and&#xD;
             side effects, unable to complete the test plan and follow-up workers (systematic&#xD;
             evaluation is required before the trial is enrolled).&#xD;
&#xD;
         14. No personal freedom and independent civil capacity.&#xD;
&#xD;
         15. The investigator determined that the patient could not obtain long-term follow-up data&#xD;
             (due to unavailability or serious concomitant diseases).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female breast cancer patients</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoming Zha, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Jue Wang</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>neoadjuvant chemotherapy</keyword>
  <keyword>Axillary lymph nodes positive</keyword>
  <keyword>Carbon-tattooed Lymph Nodes</keyword>
  <keyword>locating clip</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>Adrenocorticotropic Hormone</mesh_term>
    <mesh_term>Melanocyte-Stimulating Hormones</mesh_term>
    <mesh_term>beta-Endorphin</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/NCT04482803
org study id: NBC Sur001
nct id: NCT04482803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To explore the feasibility of target biopsy of carbon nanoparticles labelled lymph node after
      neoadjuvant systemic therapy for cN+ breast cancer, and evaluate whether it can accurately
      predict axillary lymph node status after neoadjuvant systemic therapy.
Locally advanced breast cancer patients with clinical assessed positive axillary lymph node
      (cN+) who receive neoadjuvant systemic therapy (NST) will be enrolled in this study. Before
      NST, one of the suspected lymph nodes will be subjected to ultrasound-guided core needle
      biopsy (CNB) or fine needle aspiration (FNA), and a locating clip will be placed. Meanwhile,
      a small amount of Kanarine (Carbon Nanoparticles Suspension Injection) will be injected into
      or around the cortex of the locating lymph node as well as other positive lymph nodes. All
      patients will be confirmed to have axillary lymph node metastasis by pathologic or cytologic
      examination. After NST, FNA will be performed again for the lymph nodes labelled with
      previous locating clip. During the operation, the clip labelled lymph nodes were identified
      with carbon and sent to pathology separately. Meanwhile, the remaining carbon labelled lymph
      nodes were also separately examined. Axillary lymph node dissection will be performed in all
      patients. The detection rate of labelled lymph node will be record, and the pathological
      results of re-FNA of labelled lymph nodes will be compared with postoperative pathological
      results. Meanwhile, we will also analysis whether carbon labelled lymph node biopsy could
      predict the overall status of axillary lymph nodes after NST.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes
time frame: 1-3 day before NST, the suspected lymph nodes will be injected carbon nanoparticle. During operation, carbon nanoparticle labelled lymph nodes will be identified and sent for examination.
description: Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip will be placed, meanwhile, a small amount of carbon nanoparticles suspension injection will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. During operation, carbon nanoparticle labelled lymph nodes will be identified and sent for examination. Then calculate the accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes for postoperative pathology.
measure: The consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.
time frame: 1-3 day before NST, one of the cN+ nodes will be placed a locating clip. 1-3 days before surgery, the clip labeled node will be punctured again. During operation, the clip labeled node will be identified and sent for examination.
description: Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip will be placed. Before surgery, the clip labeled node will be punctured (FNA) again. During operation, the clip labeled node will be identified and sent for pathological examination. And then calculate the identification rate of labeled lymph nodes and the consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.
arm group label: Carbon nanoparticles labelled lymph nodes group
arm group type: Experimental
description: Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes before NST.
intervention type: Drug
intervention name: Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes
description: Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip (Ultraclip, BARD) will be placed. Meanwhile, a small amount of Kanarine (carbon nanoparticles suspension injection, 0.5ml:25mg, H20073246) will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. Preoperative FNA will be performed again for locating clip labelled node.
arm group label: Carbon nanoparticles labelled lymph nodes group
other name: A locating clip was placed in one of the suspected lymph nodes
other name: Preoperative FNA will be performed again for locating clip labelled node
criteria: 
gender: Female
gender based: Yes
gender description: Female breast cancer patients
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xiaoming Zha, Doctor
role: Study Director
affiliation: The First Affiliated Hospital with Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Jue Wang
investigator title: Prof.
mesh term: Breast Neoplasms
mesh term: Adrenocorticotropic Hormone
mesh term: Melanocyte-Stimulating Hormones
mesh term: beta-Endorphin
sharing ipd: No