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临床试验/NCT02084784
NCT02084784已完成不适用

Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients

Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Sentinel lymph node detection rate

研究概览

简要总结

The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

详细描述

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, the investigators introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. The investigators aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Indocyanine green & methylene blue,

Experimental

Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5%

干预措施: Indocyanine green (Drug)

Indocyanine green & methylene blue,

Experimental

Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5%

干预措施: methylene blue (Drug)

结局指标

主要结局

Sentinel lymph node detection rate

时间窗: 1 year

Participants will be followed for the duration of hospital stay, an expected average of 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Chongwei Chi, Ph.D

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Chinese Academy of Sciences

研究点 (1)

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