Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Specimen volume
研究概览
简要总结
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.
详细描述
The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Planned for preoperative chemotherapy before breast cancer surgery
- •Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
- •SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
- •Signed and dated written informed consent before the start of specific protocol procedures
排除标准
- •Pregnant or breast-feeding
- •Iron overload disease
- •Known hypersensitivity to iron or dextran compounds
- •Inability to understand given information and give informed consent or undergo study procedures
- •Planned MRI control for tumour response during chemotherapy
结局指标
主要结局
Specimen volume
时间窗: Perioperatively
The surgical specimen is weighed after removal.
次要结局
未报告次要终点
研究者
Professor Fredrik Warnberg
professor
Sahlgrenska University Hospital