UW26028: Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Proportion of verification image assessments resulting in an adaptive replanning decision
研究概览
简要总结
Researchers are doing this study to better understand how certain treatment planning and clinical workflow software systems support the delivery of standard-of-care proton radiation therapy.
The main question it aims to answer is how well the software works in the workflow.
Participants will receive proton therapy.
详细描述
This study is being done to evaluate the clinical utilization and safety of RayStation 2025 and RayCare 2025 treatment planning software upgrades when used to support standard-of-care proton therapy delivery in patients deemed clinically appropriate for such therapy by their treating radiation oncologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Age ≥ 18 years at the time of consent.
- •Participant is deemed clinically appropriate for standard-of-care proton therapy by treating radiation oncologist and will not require anesthesia for therapy.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participant has contraindications to proton therapy (per standard clinical guidelines).
- •Participant is unable to comply with routine treatment workflow or follow-up.
- •Participants who will be treated with a radiation plan of 5 fractions or fewer.
研究组 & 干预措施
Treatment Planning Software
干预措施: Treatment Planning Software (Device)
结局指标
主要结局
Proportion of verification image assessments resulting in an adaptive replanning decision
时间窗: From the first verification image assessment through completion of proton therapy, up to 22 weeks
Proportion of evaluable verification image assessments that result in an order for repeat CT simulation and/or treatment plan reoptimization. Each verification image assessment is classified as resulting or not resulting in an adaptive replanning decision.
次要结局
- Concordance of RayAdaptive-predicted inadequate target coverage with repeat CT simulation findings(From the first verification image assessment through completion of proton therapy, up to 22 weeks)
- Number of software-related adverse events and device deficiencies(During proton therapy and through 90 days after completion of proton therapy)
- Proportion of adaptive replanning decisions influenced by RayTracker/RayAdaptive(From the first verification image assessment through completion of proton therapy, up to 22 weeks)
- Concordance of RayAdaptive-predicted organ-at-risk dose constraint violations with repeat CT simulation findings(From the first verification image assessment through completion of proton therapy, up to 22 weeks)