NCT00417495已完成2 期
Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 20
- 主要终点
- detection rate of sentinel nodes
研究概览
简要总结
The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer
详细描述
The sentinel lymph node is located preferentially by:
- association of subareolar injection of technecium and blue dye
- or, in case of blue dye allergy, by the subareolar injection of technecium only
- or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery
- This procedure is immediately follows by complete axillary dissection during breast surgery
- The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Multifocal invasive breast cancer
- •At least 2 focuses (clinically and/or by mammography or ultrasound)
- •Proven by pre-surgical histology (on 1 focus at least)
- •Age > 18 years old
- •Clinically negative axillary lymph nodes
- •No treatment before surgery
- •Signature of written informed consent
排除标准
- •Multifocality proven after surgery
- •Non invasive breast cancer
- •Inflammatory breast cancer
- •Axillary lymph node
- •Metastatic disease
- •Previous homolateral breast cancer
- •Dementia or alterated mental status
- •Pregnant or lactating woman
结局指标
主要结局
detection rate of sentinel nodes
时间窗: surgery
次要结局
- number of sentinel nodes removed(surgery)
- localisation of the sentinel nodes(surgery)
研究者
研究点 (20)
Loading locations...
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