A Prospective Imaging Study of Target Definition and Radiation Planning Workflows on the Integrated TrueBeam-HyperSight System for Patients Receiving Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of using HyperSight CBCT images for radiation treatment planning.
研究概览
简要总结
Cone beam computed tomography (CBCT) images are routinely used in radiation treatment delivery workflows to align patients with the treatment beam. Conventional CBCT image quality is sufficient for this task but not good enough for other radiotherapy-related tasks, such as contouring anatomical structures and calculating radiation dose distributions. HyperSight is a new CBCT imaging system manufactured by Varian Medical Systems. The purpose of this study is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam radiotherapy system, a linear accelerator with a C-arm gantry that rotates about the patient to delivery radiation to the target malignancy. HyperSight CBCT images will be acquired prospectively from patients who are receiving radiation treatment. The HyperSight/TrueBeam system will be used for imaging only; patients receive their radiation treatment on cleared devices and no aspect of their treatment is affected by participation in the study. HyperSight images collected during the study will be evaluated for quality and utility and compared to conventional CBCT images as well as fan beam CT images used for treatment planning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient is scheduled to receive radiation therapy to one of the following anatomical sites: head and neck/brain, thorax, abdomen, pelvis.
- •Patient is at least 18 years of age.
- •If the patient will be receiving IV contrast on study, patient must have adequate renal function as defined by an estimated glomerular filtration rate (eGFR) of >
- •Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented. Contrast eligibility will be determined as per Appendix A.
- •If the patient is a woman of childbearing potential, patient must have a negative pregnancy test within 30 days of enrollment and prior to any study imaging. Contraceptive use is not an adequate documentation of no chance of pregnancy.
排除标准
- •Patient is unwilling or unable to sign an IRB-approved written informed consent document.
- •Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").
研究组 & 干预措施
HyperSight Imaging arm
Subjects are imaged with the new HyperSight CBCT imaging system.
干预措施: HyperSight imaging (Device)
结局指标
主要结局
Feasibility of using HyperSight CBCT images for radiation treatment planning.
时间窗: 1-9 weeks
The percentage of images that are of sufficient quality for patient treatment plan generation.
次要结局
未报告次要终点