A ProSPEctivE Study of NGDS DMAT Workflow Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the feasibility of the mock NGDS DMAT workflow under breath hold conditions.
研究概览
简要总结
The purpose of this research is to evaluate the "Next Generation Delivery System" (NGDS) and determine if this machine will be more efficient at delivering radiation in shorter treatment time and better patient tolerance, with less breath holding.
详细描述
This study is a prospective multi-center clinical trial. It is designed to evaluate the feasibility of a breath hold workflow on a new treatment platform (NGDS DMAT).
Eligible participants will be receiving stereotactic body radiotherapy (SBRT) under breath hold conditions to targets in the thorax and upper abdomen as part of their routine care.
Enrolled participants will be asked to undergo a mock treatment on this new treatment platform under breath hold conditions. Participant images for set up and alignment will be obtained on the NGDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Target lesions in the thorax or upper abdomen
- •Planned to undergo SBRT radiation treatment delivered on a conventional "C-arm" or ring gantry CBCT guided linear accelerator under breath hold conditions
- •ECOG performance status 0-1
- •At least 21 years of age
- •Able to sign informed consent
排除标准
- •Participants enrolled in another clinical investigation the investigator believes to be in conflict with this clinical investigation.
- •Participants with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.
研究组 & 干预措施
Single Arm - All patients will be treated the same
"Mock" treatment on the NGDS machine.
干预措施: Next Generation Delivery System (NGDS) (Device)
结局指标
主要结局
To evaluate the feasibility of the mock NGDS DMAT workflow under breath hold conditions.
时间窗: From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months
Feasibility of the mock NGDS DMAT treatment workflow under breath hold conditions will be confirmed following successful execution of each step: 1. Acquisition of an IDENTIFY-monitored breath hold kV HyperSight CBCT 2. Conduct verification imaging of shifts and breath hold position using kV fluoroscopy 3. Delivery of an investigator approved "mock" DMAT treatment plan
次要结局
- To quantify the number of breath holds required.(From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months)
- To assess the participant's experience of the conventional treatment and mock NGDS DMAT treatment.(From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months)
- To quantify all temporal aspects of the NGDS DMAT and conventional treatment sessions.(From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months)
- To create a DMAT dosimetry plan judged clinically acceptable for treatment.(From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months)
- To assess patient-specific quality assurance results for DMAT plans.(From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months)
- To assess the feasibility of intra-fraction motion monitoring with triggered imaging.(From enrollment to end of "mock" treatment of last participant enrolled, assessed up to 6 months)