Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry Optional Sub-Study I: ICG Optional Sub-Study II: OTL38
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
- Tissue to Background Ratio
研究概览
简要总结
The study objective is to collect prospective data on cancer patients 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.
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 esophagogastric or bladder cancer.
- •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 population.
结局指标
主要结局
Tissue to Background Ratio
时间窗: 2 years
Enhance ability to detect malignant tissues in situ and ex vivo.
次要结局
未报告次要终点