Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
研究概览
简要总结
In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.
详细描述
Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Operable breast cancer patient
- •Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection
排除标准
- •Breast cancer history
- •Occult breast cancer
- •Past history of axillary surgery
- •Iodine hypersensitivity
- •Pregnancy
研究组 & 干预措施
Selective Lymph Node Dissection
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.
干预措施: Axillary lymph node dissection (Procedure)
Selective Lymph Node Dissection
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.
干预措施: Indocyanine green (Drug)
Selective Lymph Node Dissection
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.
干预措施: Imaging devices (Device)
结局指标
主要结局
Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
时间窗: within 2 weeks (plus or minus 3 days) after surgery
Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.
次要结局
- Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes(within 2 weeks (plus or minus 3 days) after surgery)
研究者
Seok Won Kim
Associate professor
Samsung Medical Center