Clinical Trial

Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study

Active, Not Recruiting
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Summary
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.
Trial Details
NCT Number NCT07032220
Lead Sponsor Fujian Medical University Union Hospital
Conditions Breast Cancer Surgery, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy (SLNB)
Enrollment 175 participants
Start Date 2024-12-09
Primary Completion 2027-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-22