Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location
研究概览
简要总结
To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.
详细描述
Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •invasive ductal carcinoma diagnosed by biopsy;
- •clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;
- •NAC regimen followed the NCCN guideline;
- •no prior history of breast cancer or other malignancies.
排除标准
- •the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
结局指标
主要结局
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location
时间窗: During the surgery
After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from Level III to Level II, and from Level II to Level I. This means that if the nodes at Level I are negative, the nodes at Level II or Level III will be negative; if the nodes at Level II are negative, the nodes at Level III will be negative; if the nodes at Level III are positive, the nodes at Level I and Level II will be positive.
次要结局
- The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location(During the surgery)
- The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location(During the surgery)
研究者
Jianyi Li
Principal Investigator
Shengjing Hospital