A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Comparison of Image Contrast Resolution
研究概览
简要总结
Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow.
Varian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image.
This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can improve the process of delivering radiation treatments.
The goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan.
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 age ≥ 18
- •Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
- •A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered
排除标准
- •Patient has ECOG Performance Status ≥
- •Patient is wheelchair bound.
- •Patient has a life expectancy <3 months.
- •Patient is unwilling or unable to provide informed consent to participate in the study.
- •Patient is pregnant or has plans for pregnancy during the period of treatment.
- •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"). This includes prisoners.
研究组 & 干预措施
HyperSight Imaging Arm
干预措施: Comparison of HyperSight CBCT imaging to conventional CBCT imaging. (Device)
结局指标
主要结局
Comparison of Image Contrast Resolution
时间窗: End of radiation treatment at 9 weeks.
The difference in contrast resolution will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process
Comparison of Image Uniformity
时间窗: End of radiation treatment at 9 weeks.
The difference in image uniformity will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process.
Qualitative Image Comparison
时间窗: End of radiation treatment at 9 weeks.
Qualitative comparison of HyperSight CBCT to conventional CBCT to determine preferred imaging for patient localization for daily treatment. Clinician observers will rank their preference using a 5-point Likert scale, where 1 represents strong preference of one imaging modality and 5 represents strong preference for the other modality.
次要结局
- Reduction of Metal Artifacts(End of radiation treatment at 9 weeks.)
- Imaging Time for Large Treatment Volumes(End of radiation treatment at 9 weeks.)
- Imaging Time for Breath Hold Imaging(End of radiation treatment at 9 weeks.)
- Patient Tolerance of Breath Hold Imaging(End of radiation treatment at 9 weeks.)
- Feasibility of HyperSight CBCT for Treatment Planning(End of radiation treatment at 9 weeks.)