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临床试验/NCT07323966
NCT07323966招募中不适用

Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Stability of patient's position

研究概览

简要总结

The aim of this study is to investigate the technical feasibility of brain radiotherapy without immobilization masks using surface imaging to ensure accurate patient positioning and continuous motion monitoring.

详细描述

In brain radiotherapy, immobilization using a thermoplastic mask is a standard practice to ensure treatment accuracy. However, this method causes discomfort and anxiety for patients. The development of surface imaging (Surface Guided Radiation Therapy, SGRT) could offer a solution to this problem. SGRT is a non-invasive and non-ionizing imaging technique that uses cameras to capture the patient's position in real-time. In mask-free treatment, the radiation beam can be interrupted when motion exceeds a certain threshold and restarts only when the position is corrected.

Nowadays, very few studies have examined the concept of radiation therapy without immobilization masks using SGRT.

As part of this study, participants will take part in a simulated mask-free session. We will determine the stability of the patient's position in the absence of a mask. Participants will also complete questionnaires concerning their feelings during sessions with and without masks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Age >= 18 years old
  • Brain tumor treated with fractionated radiotherapy
  • Able to read and complete a questionnaire in French

排除标准

  • Inability to remain still

研究组 & 干预措施

Radiotherapy session without mask

Experimental

A radiotherapy session without a mask will be simulated twice (during the first week and last week of treatment) during two scheduled treatment sessions.

干预措施: Surface Guided Radiation Therapy without mask (Device)

结局指标

主要结局

Stability of patient's position

时间窗: Through the course of radiation therapy (up to 6 weeks)

The stability of the patient's position will be assessed: * on the basis of "internal" movements (of the skull) detected by scanner imaging before and after the simulated session (on-board CBCT) * on the basis of surface movements monitored by SGRT throughout the session.

次要结局

  • Patient's feelings with and without the mask(Through the course of radiation therapy (up to 6 weeks))
  • Preference of treatment(Through the course of radiation therapy (up to 6 weeks))

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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