- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04482803
Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for cN+ Breast Cancer
July 11, 2023 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
Completed
Conditions
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
Interventional
Enrollment (Actual)
159
Phase
- 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
- Name: Jue Wang, Doctor
- Phone Number: 00862568308172
- Email: wangjue200011@njmu.edu.cn
Study Contact Backup
- Name: Rui Chen, Master
- Phone Number: 00862568308172
- Email: 15951756315@163.com
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- The First Affiliated Hospital of Nanjing Medical University
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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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
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 |
Intervention / Treatment |
---|---|
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.
|
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:
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What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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)
September 24, 2020
Primary Completion (Actual)
December 2, 2022
Study Completion (Actual)
May 24, 2023
Study Registration Dates
First Submitted
July 4, 2020
First Submitted That Met QC Criteria
July 18, 2020
First Posted (Actual)
July 23, 2020
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenocorticotropic Hormone
- Melanocyte-Stimulating Hormones
- beta-Endorphin
Other Study ID 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
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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