Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hypotesis 1
研究概览
简要总结
A prospective pilot study in the Czech Republic examining the use of magnetic seed Sirius Pintuition for the localization of non-palpable malignant breast tumors and pathological lymph nodes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •breast cancer confirmed by a core-cut biopsy
- •localisation of non-palpable breast cancer or pathological lymph node with a magnetic seed Sirius Pintuition
- •breast cancer surgery in Surgical dpt, Silesian Hospital in Opava
排除标准
- •disagree with participation in the study
结局指标
主要结局
Hypotesis 1
时间窗: 1 year
Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence of complications during intraoperative marker detection (absolute and relative incidence; %).
Hypotesis 1_1
时间窗: 1 year
Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence of complications during marker insertion (absolute and relative incidence; %).
Hypotesis 1_2
时间窗: 1 year
Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence seed migration (absolute and relative incidence, %).
次要结局
- Hypotesis 2(1 year)
- Hypotesis 2_1(1 year)
研究者
Jan Žatecký
Jan Žatecký, MD, PhD, Principal Investigator
Silesian Hospital in Opava