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临床试验/NCT07116759
NCT07116759已完成不适用

Real-Time Head Position Stabilization of Healthy Volunteers

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients

研究概览

简要总结

A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive and since healthy volunteers are enrolled in this study, no radiation is delivered, but in the future, the investigators plan to use this device during radiation treatment with patients.

详细描述

This study aims to passively monitor the real-time head motions of healthy volunteers positioned to simulate whole brain radiation therapy. Such real-time head motion data is necessary in order to understand the type (amplitude/frequency) of motion that the robotic stage will be expected to compensate for and will play an important role in the overall modeling and designing process of the robotic prototype.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Subjects 18 and older
  • Subjects must be able to read and understand English
  • Participants must sign the informed consent form

排除标准

  • Any subjects not meeting the above inclusion criteria will not be considered for this study.

研究组 & 干预措施

Healthy Volunteers

The volunteer population will consist of healthy individuals.

干预措施: Real-time head stabilization with robotic platform (Device)

结局指标

主要结局

Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients

时间窗: One-time session, up to 4 hours on a single day.

Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of \< 1.0 mm translational and \< 1.0° rotational deviation was chosen as the single primary outcome measure.

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 (2)

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