Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Time to sentinel lymph node biopsy
研究概览
简要总结
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.
In this study, our hypotheses are as following:
- Multimodal method enables to increase identification rate of SLNB
- blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
- Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy
详细描述
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision
Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes
Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •clinically lymph node negative breast cancer patients
- •consented patients with more than 20 years
排除标准
- •history of breast cancer
- •locally advanced breast cancer and metastatic breast cancer
- •proven axillary lymph node metastasis
- •history of axillary excisional or incisional biopsy, or dissection
- •history of neoadjuvant chemotherapy
- •pregnancy
- •non-consented patients
- •younger than 20 years old
研究组 & 干预措施
radioisotope
sentinel lymph node operation using radioisotope in the breast cancer patients
干预措施: radioisotope (Device)
the mixture including indocyanine green
sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients
干预措施: the mixture including indocyanine green (Device)
结局指标
主要结局
Time to sentinel lymph node biopsy
时间窗: up to 6 months
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).
次要结局
- Identification rate of sentinel lymph node biopsy(13 months)
研究者
So-Youn Jung
Medical Doctor
National Cancer Center, Korea