FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence
研究概览
简要总结
The purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection/sampling.
This trial is a single-site cross-sectional study. The injection of ICG directly into lymphatics draining the primary tumor will take place at the time of operation after the patient is under anesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any pediatric patient (under the age of 18 years) being treated at the University of Rochester Medical Center, Department of Surgery.
- •Diagnosed with pediatric solid tumor
- •Scheduled to undergo lymph node sampling as part of their clinical management.
排除标准
- •Subjects with a history of iodide allergies.
- •Inability or unwillingness of research participant or parent/legal guardian to give written informed consent.
- •Currently pregnant.
- •Infants under 650 grams.
- •Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
研究组 & 干预措施
Indocyanine Green (ICG) and KARL STORZ ICG Imaging System
干预措施: ICG (Indocyanine Green) (Diagnostic Test)
结局指标
主要结局
Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence
时间窗: Baseline
Success is defined as the intraoperative identification of at least one fluorescent sentinel lymph node (SLN) after indocyanine green (ICG) injection using an Iridium system optimized for near-infrared detection. Visualization of the SLN indicates uptake of ICG within the lymphatic basin.
Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence
时间窗: Baseline
Success is defined as the intraoperative identification of at least one fluorescent sentinel lymph node (SLN) after indocyanine green (ICG) injection using an Iridium system optimized for near-infrared detection. Visualization of the SLN indicates uptake of ICG within the lymphatic basin.
次要结局
未报告次要终点
研究者
Hafeez Abdel
Associate Professor - Department of Surgery, Pediatric Surgery (SMD)
University of Rochester