Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
研究概览
简要总结
The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy)
- •approval and informed consent
排除标准
- •chemotherapy
- •locoregional radiotherapy
- •prevalent axillary lymph node
结局指标
主要结局
Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
次要结局
- Comparison of the results of SLN serial sectioning, with H&E and IHC staining
- Economical evaluation of SLN procedure.