Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Percentage of patients with grade 3 or higher adverse events related to ICG use
研究概览
简要总结
The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area.
Primary Objectives
- To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors.
- To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.
详细描述
During surgery, participants will be given the dye to help the doctor see the lymph nodes to be removed. Pictures or a video of the procedure will be done. The number of lymph nodes removed will be recorded. After surgery, the lymph nodes will be examined.
Participants will be followed for up to 24 hours after surgery to determine if there were any side effects from the dye.
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 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection.
排除标准
- •Subjects with a history of iodide allergies.
- •Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- •Pregnant female.
- •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)
Participants will receive Indocyanine green intraoperatively.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Percentage of patients with grade 3 or higher adverse events related to ICG use
时间窗: From the time of ICG administration to 24 hours after surgery (post-surgery)
Adverse Events will be captured from the time of ICG administration to 24 hours post-surgery. Adverse Events will be graded by this scale: the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful
时间窗: During surgery (Intraoperatively)
The estimated percentage of ICG identification and its confidence interval (CI) based on the Pearson-Klopper method exact method will be calculated.
次要结局
未报告次要终点