Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)
研究概览
简要总结
The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.
详细描述
This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Stage 0,I, II breast cancer
- •Clinical node status N0, N1
- •No know allergy to iodine, lymphazurin or methylene blue dyes
排除标准
- •Patient cannot be pregnant or nursing
- •Prisoners will not be eligible
- •Women under the age of 18 will not be eligible
- •Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes
研究组 & 干预措施
1
One arm diagnostic
干预措施: Methylene blue (Drug)
结局指标
主要结局
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)
时间窗: intraoperatively; up to 6 hours
次要结局
- Superficial Skin Necrosis(2 weeks postoperatively)
- Safety (Allergic Reaction to Blue Dye)(intraoperatively up to 6 hours)
研究者
Varney Rannells
Research Coordinator
Louisiana State University Health Sciences Center in New Orleans