Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Enhancement in axilla
研究概览
简要总结
Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.
详细描述
Volunteer patients who has underwent to NSM at least more than 6 months prior will be included to the study. Radioisotope will be injected via intradermal route to the breast underwent to NSM patients and lymphoscintigraphy images will be obtained to detect activity in axilla. If hot nodule is detected then it will be concluded that SLNB can be performed after NSM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •NSM with/without SLNB at least 6 months prior to this study -
排除标准
- •previous axillary dissection and active breast cancer
研究组 & 干预措施
Axilla no touch
Volunteer patients who did not underwent to SLNB or axillary lymph node dissection during previous NSM
干预措施: Senti-Scint (99mTc- pertechnetate combined with human albumin) (Diagnostic Test)
Axilla with previous SLNB
Volunteer patients who has underwent to SLNB but not axillary lymph node dissection during previous NSM
干预措施: Senti-Scint (99mTc- pertechnetate combined with human albumin) (Diagnostic Test)
结局指标
主要结局
Enhancement in axilla
时间窗: 4 hours after injection
Hot nodules will be showed in axilla after injection of SENTI-SCINT
次要结局
未报告次要终点
研究者
Halil KARA
Principal Investigator
Acibadem University