Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Identification rate of sentinal lymph node biopsy
研究概览
简要总结
This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.
Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.
In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.
详细描述
- 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging
- sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).
- indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.
- using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.
- ICG can be visualized with a fluorescence imaging system
- confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •breast cancer patients who receive neoadjuvant chemotherapy
- •cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
- •ECOG Performance status 0 or 1
- •consented patients with more than 20 years, less than 70 years
排除标准
- •history of breast cancer
- •early stage breast cancer
- •history of excisional or incisional biopsy or axillary dissection
- •inflammatory breast carcinoma
- •cN3 on tumor lymphnode metastasis classification(TNM)
- •history of hormone therapy or targeted therapy
- •stage 4 breast cancer
- •pregnancy
结局指标
主要结局
Identification rate of sentinal lymph node biopsy
时间窗: during operation
It was defined as the ability to identify a sentinel lymph node successfully.
次要结局
- duration of sentinel lymph node biopsy(during operation)
研究者
Seeyoun Lee
Medical Doctor
National Cancer Center, Korea