Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for CN+ Breast Cancer

October 11, 2024 updated by: Jue Wang, The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female breast cancer patients who received neoadjuvant systemic chemotherapy, aged 18-70 years old, with clinically assessed positive lymph node, and the expected survival period is greater than 12 months.
  2. No previous radiotherapy and chemotherapy.
  3. No history of serious systemic disease.
  4. KPS≥70.
  5. White blood cell count> 3.5 × 10 ^ 9 / L, neutrophil count> 1.8 × 10 ^ 9 / L, platelet count> 100 × 10 ^ 9 / L, hemoglobin> 9 g / dl.
  6. ALT and AST <1.5 times the upper limit of normal value, alkaline phosphatase <2.5 times the upper limit of normal value, and total bilirubin <1.5 times the upper limit of normal value.
  7. Serum muscle plasma <1.5 times the upper limit of normal value.
  8. No abnormal blood coagulation.
  9. Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment.
  10. Cardiac function: two-dimensional echocardiography examination LVEF ≥ 55%.
  11. Sign informed consent.

Exclusion critia:

  1. Received systemic or local treatment for tumors, including chemotherapy, radiotherapy and endocrine therapy.
  2. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
  3. The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
  4. Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression and other diseases, can not tolerate chemotherapy related treatments.
  5. Two-dimensional echocardiography detection LVEF <55%.
  6. Severe cardiovascular and cerebrovascular diseases within the first 6 months of randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension> 150/90 mmHg, myocardial infarction or cerebrovascular accident).
  7. NCI peripheral neurotoxicity grade ≥2.
  8. Those taking glucocorticoids.
  9. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab or pertuzumab.
  10. Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
  11. Pregnant and lactating women.
  12. After joining the test, a pregnancy test (+) before using the drug.
  13. There are mental illness, cognitive impairment, unable to understand the test plan and side effects, unable to complete the test plan and follow-up workers (systematic evaluation is required before the trial is enrolled).
  14. No personal freedom and independent civil capacity.
  15. The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Carbon nanoparticles labelled lymph nodes group
Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes before NST.
Drug: Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes
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.
Other Names:
  • A locating clip was placed in one of the suspected lymph nodes
  • Preoperative FNA will be performed again for locating clip labelled node

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xiaoming Zha, Doctor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBC Sur001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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