EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
研究概览
简要总结
The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age 18 years or older,
- •Scheduled to undergo fiducial placement,
- •Subject must be able to give informed consent
排除标准
- •Any contraindication to performing endoscopy,
- •Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
- •The subject is unable/unwilling to give informed consent
结局指标
主要结局
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
时间窗: approximately one week
The outcome measure for this study is to determine: 1. The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system, 2. The accuracy of the fiducial delivery into the targeted tissue and 3. to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan. The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.
次要结局
未报告次要终点