Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 699
- 试验地点
- 1
- 主要终点
- To continue gathering data relating to the sentinel lymph node biopsy procedure.
研究概览
简要总结
We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.
详细描述
Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.
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
- 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
- •Breast cancer requiring lymph node evaluation
- •Clinically negative lymph nodes in the axilla
- •Willing participation following an informed consent process
排除标准
- •Patients with clinically positive lymph nodes
- •Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis)
- •Previous axillary lymphadenectomy
研究组 & 干预措施
1
干预措施: Sentinel Node Biopsy (Procedure)
结局指标
主要结局
To continue gathering data relating to the sentinel lymph node biopsy procedure.
时间窗: Time of surgery and data analysis
次要结局
- To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid.(Time of surgery and data analysis)