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

Primary Purpose

Location and Biopsy of Axillary Lymph Nodes

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes

About this trial

This is an interventional diagnostic trial for Location and Biopsy of Axillary Lymph Nodes focused on measuring Breast cancer, neoadjuvant chemotherapy, Axillary lymph nodes positive, Carbon-tattooed Lymph Nodes, locating clip

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.
No previous radiotherapy and chemotherapy.
No history of serious systemic disease.
KPS≥70.
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.
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.
Serum muscle plasma <1.5 times the upper limit of normal value.
No abnormal blood coagulation.
Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment.
Cardiac function: two-dimensional echocardiography examination LVEF ≥ 55%.
Sign informed consent.

Exclusion critia:

Received systemic or local treatment for tumors, including chemotherapy, radiotherapy and endocrine therapy.
A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
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.
Two-dimensional echocardiography detection LVEF <55%.
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).
NCI peripheral neurotoxicity grade ≥2.
Those taking glucocorticoids.
Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab or pertuzumab.
Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
Pregnant and lactating women.
After joining the test, a pregnancy test (+) before using the drug.
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).
No personal freedom and independent civil capacity.
The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).

Sites / Locations

the First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carbon nanoparticles labelled lymph nodes group

Arm Description

Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes before NST.

Outcomes

Primary Outcome Measures

The accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary 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 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.

Secondary Outcome Measures

The consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.

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.

Full Information

NCT ID

NCT04482803

First Posted

July 4, 2020

Last Updated

July 11, 2023

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04482803

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 24, 2020 (Actual)

Primary Completion Date

December 2, 2022 (Actual)

Study Completion Date

May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Location and Biopsy of Axillary Lymph Nodes

Keywords

Breast cancer, neoadjuvant chemotherapy, Axillary lymph nodes positive, Carbon-tattooed Lymph Nodes, locating clip

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carbon nanoparticles labelled lymph nodes group

Arm Type

Experimental

Arm 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(s)

Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes

Other Intervention Name(s)

A locating clip was placed in one of the suspected lymph nodes, Preoperative FNA will be performed again for locating clip labelled node

Intervention 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.

Primary Outcome Measure Information:

Title

The accuracy of carbon nanoparticle labelled lymph nodes in predicting axillary lymph nodes

Description

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.

Secondary Outcome Measure Information:

Title

The consistency between the pre-operative FNA of clip labeled lymph nodes and post-operative pathology.

Description

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.

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female breast cancer patients

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. No previous radiotherapy and chemotherapy. No history of serious systemic disease. KPS≥70. 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. 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. Serum muscle plasma <1.5 times the upper limit of normal value. No abnormal blood coagulation. Women of childbearing age had a negative serum or urine pregnancy test before the start of treatment and agreed to contraception during treatment. Cardiac function: two-dimensional echocardiography examination LVEF ≥ 55%. Sign informed consent. Exclusion critia: Received systemic or local treatment for tumors, including chemotherapy, radiotherapy and endocrine therapy. A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ). The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study. 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. Two-dimensional echocardiography detection LVEF <55%. 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). NCI peripheral neurotoxicity grade ≥2. Those taking glucocorticoids. Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab or pertuzumab. Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age. Pregnant and lactating women. After joining the test, a pregnancy test (+) before using the drug. 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). No personal freedom and independent civil capacity. The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoming Zha, Doctor

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Study Director

Facility Information:

Facility Name

the First Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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