Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Therapy(Chemotherapy, Hormonal Therapy, Targeted Therapy); Clinical Study for 130 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Identification rate of sentinel lymphnode biopsy
研究概览
简要总结
This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.
To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.
详细描述
Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin.
Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near infrared fluorescence camera visualized during surgery.
As investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.
Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.The protocol required that 130 patients who receive neoadjuvant chemotherapy.
In this study investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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 therapy (chemotherapy,hormonal therapy, targeted therapy)
- •cN1-cN2 or cN3( but must be complete response status)on tumor lymphnode metastasis classification( TNM) after neoadjuvant therapy.
- •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)
- •stage 4 breast cancer
- •pregnancy
研究组 & 干预措施
Radioisotope (RI)
Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy.
Interventions - patient assigend RI groups are injected only RI
-
fill the Primay Case Report Form during surgery
-
PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .
干预措施: Indocyanine green (Drug)
Radioisotope (RI)
Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy.
Interventions - patient assigend RI groups are injected only RI
-
fill the Primay Case Report Form during surgery
-
PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .
干预措施: Radioisotope (Drug)
Indocyanine green (ICG) +RI
Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.
Interventions - patient assigend RI groups are injected RI +ICG
-
prepare fluorescence camera when the surgery begin
-
surgeon uses the camera to decect fluorescence flow on SLN
-
fill the Primay Case Report Form during surgery
-
PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-
干预措施: Indocyanine green (Drug)
Indocyanine green (ICG) +RI
Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.
Interventions - patient assigend RI groups are injected RI +ICG
-
prepare fluorescence camera when the surgery begin
-
surgeon uses the camera to decect fluorescence flow on SLN
-
fill the Primay Case Report Form during surgery
-
PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-
干预措施: Radioisotope (Drug)
结局指标
主要结局
Identification rate of sentinel lymphnode biopsy
时间窗: Participants will be followed for 2 weeks from operation
次要结局
- Duration of sentinel lymphnode biopsy(3months follow up from the day of operation)
研究者
Seeyoun Lee
Medical Doctor
National Cancer Center, Korea