Development and Utilization of Indocyanine Green Fluorescence Near Infrared Zone II Lymphography in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Signal-to-background ratio (SBR)
研究概览
简要总结
This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.
详细描述
Multi-wavelength fluorescence has been surveyed in various fields of surgery. However, it was still under investigation, and has not been matured for clinical use. This study will evaluate near infrared zone II spectrums for breast cancer patient undergoing sentinel lymph node mapping with near-infrared fluorescence navigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The patient will know they are going to accept near infrared zone II imaging during the sentinel lymph node biopsy procedure. They will not see the images and will not know the quality results.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer, adults
排除标准
- •Patient aged < 20 years old
- •Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
- •Patient who is allergic to primary tracers (including Tc99m and blue dye)
- •Patient who is allergic to indocyanine green
结局指标
主要结局
Signal-to-background ratio (SBR)
时间窗: through study completion, an average of 1 year
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
次要结局
- Sentinel lymph nodes pathology(through study completion, an average of 1 year)
- Penetration depth(through study completion, an average of 1 year)