Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.1
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
- Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.
研究概览
简要总结
The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient is willing and able to provide written consent.
- •Patient is at least 18 years of age at the time of consent.
- •Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
- •Patient has ECOG performance status 0-
- •Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.
排除标准
- •Patient is pregnant or attempting pregnancy.
- •Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
- •Patient receives palliative radiation for 5 or fewer fractions.
- •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
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
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.
时间窗: 1 year
To evaluate the feasibility of HyperSight CBCT as a method for CBCT-based re-planning by measuring the fraction of patients whose HyperSight imaging meets criteria for potential CBCT-based treatment planning using HyperSight CBCT. The criteria include visibility of all key anatomical structures, image quality sufficient to contour anatomical structures, and clinically acceptable dose accuracy.
次要结局
- Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site(1 year)
- Image noise(1 year)
- Image low-contrast resolution(1 year)
- Qualitative assessment of motion artifacts(1 year)
- Comparison of anatomical structure contours defined on HyperSight and conventional imaging.(1 year)
- Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site(1 year)
- Image noise(1 year)
- Image low-contrast resolution(1 year)
- Qualitative assessment of motion artifacts(1 year)
- Comparison of anatomical structure contours defined on HyperSight and conventional imaging.(1 year)
- Impact of noise suppression(1 year)
- Effectiveness of AI auto-contouring(1 year)
- Image contrast-to-noise ratio(1 year)
- Qualitative assessment of metal artifacts(1 year)
- Breath hold tolerance(1-9 weeks)
- Patient experience of HyperSight imaging(1-9 weeks)