Location and Biopsy of Axillary Lymph NodesNCT04482803
Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for CN+ Breast Cancer
A study testing Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes in people with Location and Biopsy of Axillary Lymph Nodes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Location and Biopsy of Axillary Lymph Nodes
- What is being tested?
- Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2020to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
About this study
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
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.
Read the 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.
- Being tested
- Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes
- Keywords
- Breast cancer, neoadjuvant chemotherapy, Axillary lymph nodes positive, Carbon-tattooed Lymph Nodes, locating clip
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodesDrug
Also called A locating clip was placed in one of the suspected lymph nodes, Preoperative FNA will be performed again for locating clip labelled node
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.
| Study group | Role | What they receive |
|---|---|---|
| Carbon nanoparticles labelled lymph nodes group | Experimental | Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes before NST. Receives: Drug: Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start24 Sep 2020
- Primary completion2 Dec 2022
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Location and Biopsy of Axillary Lymph NodesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue Wang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiaoming Zha, Doctor, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482803
- Sponsor's protocol ID
- NBC Sur001
- Status last verified
- Oct 2024
- First submitted
- 4 Jul 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04482803
- Acronym / sponsor ID
- NBC Sur001
- Keywords
- Breast cancer, neoadjuvant chemotherapy, Axillary lymph nodes positive, Carbon-tattooed Lymph Nodes, locating clip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon nanoparticles labelled lymph nodes group | Experimental | Drug: Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodesCarbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes before NST. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodesAlso: A locating clip was placed in one of the suspected lymph nodes, Preoperative FNA will be performed again for locating clip labelled nodeBefore 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. | Drug | Carbon nanoparticles labelled lymph nodes group |
Primary outcome
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 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Zha, Doctor study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes in people with Location and Biopsy of Axillary Lymph Nodes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.