NL-OMON40081已完成2 期
Sentinel Node Biopsy using Magnetic Nanoparticles: A prospective multicentre phase II non-randomised clinical trial to compare sentinel node biopsy using magnetic nanoparticles vs. standard technique - SentiMag Multicentre Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with breast cancer scheduled for SLNB and who are clinically and radiologically (pre-operative ultrasound normal or indeterminate/abnormal and benign FNA or core biopsy) node negative;Patients available for follow-up for at least 12 months
排除标准
- •Intolerance / hypersensitivity to iron or dextran compounds or Sienna+;Patients who cannot / do not receive radioisotope for SLNB;Patients with an iron overload disease;Patients with pacemakers or other implantable devices in the chest-wall;Intolerance / hypersensitivity to patent blue dye in centres where this is used routinely;Exlusion criteria MRI-subprotocol:;Presence of implantable devices (electronically, magnetically, mechanically activated. E.g: cardioverter defibrillators, cardiac pacemakers);Metallic splinters in the eye;Ferromagnetic haemostatic clips in the central nervous system;Claustrophobia
研究者
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