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In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. This was done to investigate the detection rate of carbon nanoparticle-labeled lymph nodes and to assess the stability and safety of carbon nanoparticles. Additionally, the dye single tracer method was employed for sentinel lymph node biopsy to evaluate the false-negative rate of TAD. This is an open-label, single-arm, multi-center prospective clinical trial. The primary objectives of this study are to evaluate the accuracy, feasibility, and safety of this method, thereby improving the quality of life and reducing postoperative complications for breast cancer patients while ensuring treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility and Accuracy of Targeted Axillary Dissection of Carbon Tattooing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon suspension | Drug | Before primary systemic therapy, a core needle biopsy or fine-needle aspiration of the most suspicious axillary lymph node was performed.22 Sterile black carbon suspension (0.5 mL: 25 mg, Chongqing LUMMY Pharmaceutical Co) was injected in the cortex of the metastatic node under ultrasound guidance using a 25G needle by a trained ultrasonographer at the time of biopsy or during a separate session. The injection volume was recorded and varied depending on node size and operator. The trained ultrasonographer had more than 5 years of puncture experience. Of note, for the patients with multiple abnormal nodes or N3 disease under ultrasound at diagnosis, only the pathologically-proven lymph node is marked with carbon suspension. |
| Measure | Description | Time Frame |
|---|---|---|
| By analyzing the detection rate of TAD, FNR and NPV, the feasibility and accuracy of this method in evaluating axillary lymph nodes of breast cancer patients after neoadjuvant therapy were evaluated. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The feasibility and accuracy of TLNB and SLNB in axillary lymph node evaluation were evaluated by analyzing the detection rate of TLNB and SLNB, FNR and NPV. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of carbon nanoparticles in breast cancer lymph node labeling | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chuan Wang | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Officials | Fuzhou | Fujian | 350001 | China |
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