ChiCTR2000038120尚未招募Unknown
Use of magnetic tracer for sentinel lymph node biopsy in breast cancer is non inferior to the standard dual tracers technique: A multi-center non-inferior randomized trial
Sponsored by endomagnetic limited2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年11月2日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Identification rate of SLN
研究概览
简要总结
Compare the identification rate between SPIO and standard dual tracers technique used in sentinel lymph node biopsy in breast cancer patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- 整群随机分组
- 盲法
- N/a
入排标准
- 性别
- Male
入选标准
- •Patient with breast cancer scheduled to have SLNB and who are clinically and radiologically node negative
排除标准
- •Patient treated with neoadjuvant chemotherapy, history of axillary radiation, history of ipsilateral axillary surgery; non palpable breast cancer requiring simultaneous localization; patient with known intolerance or hypersensitivity to iron or dextran compounds, magnetic tracers or SPIO; with an iron-overload disease; with pacemakers or other implantable devices on the chest wall; with known hypersensitivity to blue dye; who could not or did not receive radioisotope
研究组 & 干预措施
A
Magnetic tracer
B
Dual tracer
结局指标
主要结局
Identification rate of SLN
次要结局
未报告次要终点
研究者
研究点 (2)
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