Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-70 years
- •The primary breast lesion was confirmed as invasive breast cancer by core needle biopsy
- •Axillary lymph node metastasis confirmed by fine needle aspiration or core needle biopsy
- •plan to undergo neoadjuvant chemotherapy
- •operable breast cancer
- •Patients with good heart, lung, liver, and kidney function are suitable for surgery
- •Informed consent
排除标准
- •Surgery is not planned or impossible
- •Metastasis of supraclavicular lymph nodes
- •distant metastasis, excluding bone metastasis
- •previous ipsilateral axillary surgery or radiotherapy
- •Due to personal or family factors, the patient is unable to cooperate with the surgical treatment recommended by the doctor according to the condition (breast conserving surgery or radical surgery).
- •Patients with severe heart and lung diseases, uncontrolled infectious diseases and other non-tumor related diseases could not tolerate comprehensive treatment such as surgery and chemotherapy
- •Unable to sign the informed consent form due to mental illness or other reasons
- •Poor medical compliance, and the study group believed that the patients could not complete the trial treatment process and follow-up according to the standard
研究组 & 干预措施
Feasibility and Accuracy of Targeted Axillary Dissection of Carbon Tattooing
干预措施: carbon suspension (Drug)
结局指标
主要结局
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.
时间窗: 24 months
次要结局
- 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)
研究者
Chuan Wang
archiater
Fujian Medical University Union Hospital