Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intra operative identification the Spot TM marked node at the time of surgery
研究概览
简要总结
To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.
详细描述
As part of the diagnostic tests for breast cancer sometimes necessary to perform a FNA or Core biopsy to a suspicious axillary lymph node.
Presently there is no possibility to identify the examined gland at the surgery. If the gland was infected it's most important to remove it.
The only technique that exists today is marking with a metal clip and the use of this technique is not profit, partly because of technical difficulties.
In this trial the investigator will use a special ink which will be injected to the axillary lymph node during the biopsy and latter on the surgery the investigator will try to assess the ability to identify the marked gland.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy
排除标准
- •Inability to sign Informed Consent
研究组 & 干预措施
Axillary lymph node FNA Biopsy
A carbon compound ink (SPOT) is injected to the axillary lymph node suspected to be infected with cancer
干预措施: SPOT (Procedure)
结局指标
主要结局
Intra operative identification the Spot TM marked node at the time of surgery
时间窗: Within 1 year of enrollment
次要结局
- Correlation between Spot TM marked lymph node and sentinel lymph node(Within 1 year of enrollment)
研究者
Tanir M Allweis, MD
Head of Department of Breast Health Center
Kaplan Medical Center