Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dice Similarity Coefficient
研究概览
简要总结
This is a single-center, prospective pilot study evaluating the utility of HyperSight CBCT imaging and Ethos adaptive radiation planning in pediatric patients receiving radiation therapy for non-cranial tumors.
Twenty patients aged 18 or under will be enrolled. Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans. These scans will be used to assess anatomical changes and generate adapted radiation plans using the Ethos platform. Radiation oncologists and radiation therapists will independently evaluate the need for adaptation, and adapted vs. scheduled plans will be compared using dosimetric and anatomical similarity metrics.
An optional sub-study will allow anonymized imaging and planning data to be shared with Varian Medical Systems. The study duration will match the patient's treatment course, typically 1-6 weeks, with no additional follow-up beyond standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (paediatric or adolescent) age 18 or under receiving at least 5 days of radiation therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
排除标准
- •- Patients with primary cranial tumours will be excluded due to the low expected utility of non-contrast CT scans in the delineation of brain edema and brain substructures.
研究组 & 干预措施
Imaging
Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans.
干预措施: HyperSight CBCT scans (Device)
结局指标
主要结局
Dice Similarity Coefficient
时间窗: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Change in Tumor and OAR Anatomy During Pediatric Radiation Therapy Using HyperSight CBCT and Ethos Adaptive Replanning. This outcome measures how tumor and organ-at-risk (OAR) anatomy changes during pediatric radiation therapy using HyperSight CBCT.
Hausdorff distance
时间窗: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Change in Tumor and OAR Anatomy During Pediatric Radiation Therapy Using HyperSight CBCT and Ethos Adaptive Replanning. This outcome measures how tumor and organ-at-risk (OAR) anatomy changes during pediatric radiation therapy using HyperSight CBCT. This will be measured in mm.
Volume differences
时间窗: Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Change in Tumor and OAR Anatomy During Pediatric Radiation Therapy Using HyperSight CBCT and Ethos Adaptive Replanning. This outcome measures how tumor and organ-at-risk (OAR) anatomy changes during pediatric radiation therapy using HyperSight CBCT. This will be measured in cm\^3.
次要结局
- Quality of cone beam CT(From baseline to end of treatment (approximately 6 to 8 weeks))
- Organ motion(From baseline to end of treatment (approximately 6 to 8 weeks))
- Feasibility of Conformal Planning in Traditionally Field-Based Diseases(From baseline to end of treatment (approximately 6 to 8 weeks))
- Dosimetric Impact of Adaptive Radiation Therapy(From baseline to end of treatment (approximately 6 to 8 weeks))
- Safety of Minimized Target Expansion Volumes(From baseline to end of treatment (approximately 6 to 8 weeks))
- Integration of Radiation Therapy Proficiencies in Adaptive Planning(From baseline to end of treatment (approximately 6 to 8 weeks))