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临床试验/NCT03995849
NCT03995849已完成不适用

Paediatric and Adolescent Radiotherapy Without Anaesthesia Using Audio-Visual Distraction - Are the Patients Moving?

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
The proportion of patients that move between pre- and post-RT CBCT acquisitions without anaesthesia.

研究概览

简要总结

At Princess Margaret Cancer Centre, a comprehensive approach to help children stay still during radiation treatment (RT) such as audio-visual distraction (television) is routinely used. These techniques help reduce the need for sedation or general anaesthesia to keep children still to avoid the chance of missing the tumour during RT. This approach has not been systematically evaluated to determine its effectiveness at reducing movement of children receiving RT. The purpose of the study is to measure the movement of children between the beginning and the end of RT to see how much they moved during treatment.

详细描述

Cone beam CT (CBCT) is a low-dose imaging technique routinely used at Princess Margaret Cancer Centre to check the position of patients before RT. Using CBCT, the doctor is able to reduce the amount of tissues that receive RT because patients can be set-up with greater accuracy to only target the tumour and not harm the surrounding healthy tissue. In this study, children will receive one CBCT scan before starting RT as part of standard approach. Then after RT, another CBCT scan will be used to measure movement between the beginning and end of RT. The information gathered from this study will benefit other patients and cancer centres in the future, who can learn from these methods of using audio-visual distraction so that children have minimal or no motion for a more precise delivery of radiation during cancer treatment.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient (paediatric or adolescent) age 18 or under receiving RT without anaesthetic or procedural sedation (anaesthetic gas or intravenous sedative medication)

排除标准

  • Patients receiving oral midazolam or ketamine are ineligible
  • Patient is receiving total body irradiation without CBCT

结局指标

主要结局

The proportion of patients that move between pre- and post-RT CBCT acquisitions without anaesthesia.

时间窗: 12 months

To determine the proportion of patients with adequate immobilization by measuring motion between pre- and post-RT CBCT acquisitions for patients treated without anaesthesia

次要结局

  • Quantitative intra-fraction motion of patients treated with RT without anaesthesia.(12 months)
  • Factors associated with intra-fraction patient motion.(12 months)
  • Perturbations in delivered treatment dose.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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