Real Time In-Vivo Body Surface Dosimetry for External Beam Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Dosimetric accuracy of the device with reference to a commercially available dosimeter
研究概览
简要总结
This is an observational study. This protocol will determine the feasibility of using a novel nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm wide, to measure real-time, pin-point, in-vivo radiation dose given during external beam delivery of radiation therapy treatments.This new protocol is similiar in design to Pro00050297 with the significant difference being the monitoring will be performed during external baem radiotherapy.
详细描述
The device is currently in use in an ongoing IRB approved protocol Pro00050297 "Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy". Brachytherapy is an integral part of the management of many gynecological cancers, which uses radioactive isotopes to deliver radiation treatment in close proximity to the target. The protocol uses the device in the setting of gynecologic brachytherapy to monitor real time doses, with a primary endpoint of feasibility and accuracy. Accrual is ongoing, however, the device has initially given consistent results, within 3% of the expected values. This initial experience is intentionally designed with the simplest geometry and positioning. This protocol has a similar design to the initial brachytherapy trial, but with the significant difference that the monitoring will be performed during external beam radiotherapy. Calibration procedures are different in this scenario, and the considerations of when and where dose monitoring will be useful are distinct from these considerations in brachytherapy.
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
- •Histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).
- •Planned external beam radiotherapy as part of standard of care treatment
- •The radiotherapy plan involves the body surface
- •Age > 18 years
- •Able to provide and execute informed consent
排除标准
- •Allergy or previous intolerance of skin adhesives
- •Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.
结局指标
主要结局
Dosimetric accuracy of the device with reference to a commercially available dosimeter
时间窗: 24 months
次要结局
- Feasibility of clinical application of the nanaoFOD for dosimetric monitoring of external beam radiotherapy.(24 months)