Non-inferiority Study of Intra-operative Indocyanine Green Fluorescent Dye Versus Technetium Lymphoscintigraphy for Sentinel Lymph Node Biopsy in Pediatric Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- % of Patients in Whom a Sentinel Lymph Node is Identified
研究概览
简要总结
This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).
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
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients <30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy
- •Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- •Patients who are cleared for surgery
排除标准
- •History of reaction to ICG, iodides, or technetium radiocolloid
- •Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN
- •Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
- •Patients unwilling or unable to sign informed consent
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
Sentinel Lymph Node Biopsy
This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping.
干预措施: indocyanine green (ICG) (Drug)
Sentinel Lymph Node Biopsy
This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping.
干预措施: Sentinel Lymph Node Biopsy (Procedure)
结局指标
主要结局
% of Patients in Whom a Sentinel Lymph Node is Identified
时间窗: 1 year
These percentages will be compared using a non-inferiority comparison for matched pair data.
次要结局
未报告次要终点