Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy : Expanded Access Clinical Study in 3 Arms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 2
- 主要终点
- Identification rate of sentinel lymph node
研究概览
简要总结
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
详细描述
After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
- •Confirmed operability with imaging study after neoadjuvant chemotherapy
- •Age over 20 years old
- •ECOG Performance status : 0-2
- •The patient with written informed consent form
排除标准
- •The patient with previous ipsilateral breast cancer history
- •The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
- •The patient without neoadjuvant chemotherapy
- •Inoperable imaging study after neoadjuvant chemotherapy
- •Inflammatory breast cancer
- •Pregnant patient
研究组 & 干预措施
RI + ICG-F
Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.
干预措施: Radioactive Isotope (RI) Mapping (Diagnostic Test)
RI + ICG-F
Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.
干预措施: Indocyanine Green Fluorescence (ICG-F) Mapping (Diagnostic Test)
RI + Vital Dye
Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping.
干预措施: Radioactive Isotope (RI) Mapping (Diagnostic Test)
RI + Vital Dye
Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping.
干预措施: Vital Dye Mapping (Diagnostic Test)
Vital Dye + ICG-F
Participants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.
干预措施: Indocyanine Green Fluorescence (ICG-F) Mapping (Diagnostic Test)
Vital Dye + ICG-F
Participants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.
干预措施: Vital Dye Mapping (Diagnostic Test)
结局指标
主要结局
Identification rate of sentinel lymph node
时间窗: during operation
Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.
次要结局
- Comparison of operation time for sentinel lymph node biopsy(during operation)
研究者
Seeyoun Lee
Doctor, M.D., head of center for breast cancer
National Cancer Center, Korea