Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for future studies.
ICG is a dye which has been in use since the 50s, and is approved for testing liver function and measuring blood flow from the heart. It has been used in studies to map lymphatic pathways in lung and breast cancer and information from those studies suggest it may help identify lymph nodes associated with melanoma. ICG can be detected within the body using near-infrared light cameras.
In this study the investigators are looking at how easily ICG can get to the first lymph node (sentinel lymph node [SLN]) associated with melanoma, whether the investigators can see the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it does provide a small amount of radiation. This study will compare the investigators results to the standard procedure.
详细描述
At the time of surgery, you will undergo a lymphoscintigraphic procedure which is standard of care for patients with melanoma. You will also receive a dose of ICG mixed with human serum albumin. This will be administered in four small injections immediately around your tumor or the tumor scar if it has already been removed. Pictures of the ICG solution will be taken with the NIR camera and the progression of the dye along the lymphatic channel from your tumor to the SLN will be monitored.
As each lymph node is removed, pictures will be taken to see if the ICG dye has entered and colored that node. We will compare this technique with the results from the lymphoscintigraphy to measure accuracy.
Patients will be followed for at least one hour post injection for adverse events. The patient will then be taken off of the study. The results from each intervention will subsequently analyzed.
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
盲法说明
This study does not involve any masking.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed melanoma and an appropriate surgical candidate for a sentinel lymph node biopsy
- •Stage of disease conducive to sentinel lymph node biopsy as determined by oncologic surgeon
- •Receiving a planned lymphoscintigraphy procedure
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy
- •Pregnant or breast-feeding
研究组 & 干预措施
ICG Intervention
Intraoperative NIR fluorescence imaging was performed after injection of 1.0 ml of 100 µM, 250 µM or 500 µM of ICG:HSA in four quadrants around the primary lesion. (The intervention to be administered is the ICG.)
干预措施: ICG Intervention (Drug)
结局指标
主要结局
Feasibility
时间窗: We will analyze data immediately following each case, and analyze all collected data at 6 month intervals
To determine the feasibility of real-time intraoperative NIR lymphatic mapping with concurrent identification of the sentinel lymph node in human melanoma using indocyanine green.
次要结局
- Comparison of SLN identification rate between near-infrared mapping and lymphoscintigraphy.(We will analyze data immediately following each case, and analyze all collected data at 6 month intervals)
研究者
Yolonda L. Colson, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute