Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy Using the Navigation of the Combination of Indocyanine and Blue Dye in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Detection rate of SLN
研究概览
简要总结
The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.
详细描述
Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for neoadjuvant therapy
- •Have complete evaluation of the axillary status
- •Planned for axillary clearance after neoadjuvant therapy
排除标准
- •Sensitive to Iodine
- •Inflammatory disease
- •Patient's refusal to join the trial
结局指标
主要结局
Detection rate of SLN
时间窗: Immediate
The number of successful SLNB / total number of SLNB
次要结局
- False negative rate of SLNB(1 week after the surgery)
- Adverse effect(Half a year after the surgery)