Optional Sub-study to Intraoperative Imaging With ICG Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Number of tumor recurrence
研究概览
简要总结
The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.
详细描述
Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.
In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients >= 18 years of age
- •Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.
- •Good operative candidate as determined by the treating physician and/or multidisciplinary team
- •Subject capable of giving informed consent and participating in the process of consent.
排除标准
- •Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- •Vulnerable patient populations
结局指标
主要结局
Number of tumor recurrence
时间窗: 2 years
次要结局
未报告次要终点