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临床试验/NCT05178927
NCT05178927已完成不适用

UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization

University of Florida1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process.

研究概览

简要总结

The purpose of this study is to compare the accuracy, set-up time, and amount of image-guided radiotherapy (IGRT - a system that helps line up the radiation beam with the tumor for treatment) needed when mixed-reality guided radiotherapy is used for treatment set-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Targets adult patients who are planning to undergo photon or proton radiation therapy at UFHPTI for treatment of the breast or chest wall. As this type of treatment is rare in men, the study will focus on female patients only.

排除标准

  • •Male subjects

研究组 & 干预措施

Standard of Care-Group 1

Sham Comparator

During treatments 1-5, radiation therapists will position the participant for treatment using the standard of care method.

During treatments 6-10, radiation therapists will use the hologram the investigators created to initially position the participant for treatment. The participant's final position will be obtained using a standard of care method.

干预措施: HoloLens v2 (Device)

Mixed-reality guided patient setup-Group 2

Experimental

During treatments 1-5, radiation therapists will use the hologram the investigators created to initially position the participant for treatment. The participant's final position will be obtained using a standard of care method.

During treatments 6-10, radiation therapists will position the participant for treatment using the standard of care method.

干预措施: HoloLens v2 (Device)

结局指标

主要结局

Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process.

时间窗: The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks.

Counting the number of computed tomography a participant receives during radiation therapy treatment as quantified via counting the number used during the setup process

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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