Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies
Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.
Mechanical ventilation can be used to impose a completely regular pattern of breathing frequency and inflation volume on the patient for as long as required.
This would considerably improve the reproducibility of the internal motion parameters, and thus facilitate the implementation of respiratory-synchronized techniques such as gating, tracking and four-digital optimization.
研究概览
地位
完全的
详细说明
This will be a three-phase analysis :
First, different ventilation modes will be tested and compared on healthy volunteers. This phase will be analysed with a ventilator and with dynamic MRI in order to measure the movement of anatomical structures in each ventilation mode (intra-fraction analysis). Further, we will repeat these exams in order to compare them with the first ones, in order to analyse the reproducibility and baseline shifts (inter-fraction analysis).
Here are the different ventilation modes
- spontaneous breathing
- physiologic ventilation mode :
- shallow ventilation mode
- slow ventilation mode
- Jet Ventilation mode
Second phase will be done with patients that are intended to have a radiation treatment for thoracic or upper abdominal tumors. All the previous ventilation modes will be analysed during repeated MRI, again in order to perform intra- and inter-fraction analysis of the tumor motion.
Third phase also concerned patients intended to have a radiation treatment. It will be an in-silico-planning analysis in order to quantify dosimetric outcomes of these ventilation modes.
研究类型
介入性
注册 (实际的)
23
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Brussels、比利时、1200
- Cliniques Universitaires Saint-Luc
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- No comorbidity for healthy volunteers
- Cancer patients with either lung or upper abdomen (liver/pancreas) tumours treated with radiation therapy.
Exclusion Criteria:
- severe lung disease or emphysema
- previous history of pneumothorax
- claustrophobia
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Healthy volunteers on ventilation
Dynamic MRI acquisition will be performed at two different time points with 10 healthy volunteers under non-invasive mechanically-assisted ventilation with a respirator.
Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).
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Mechanically ventilation will be done through facial masks connected to a respirator.
Volunteers/patients are fully conscious during the ventilation.
Dynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation
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实验性的：Cancer patients on ventilation
Dynamic MRI acquisition will be performed at two different time points with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator.
Different modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).
|
Mechanically ventilation will be done through facial masks connected to a respirator.
Volunteers/patients are fully conscious during the ventilation.
Dynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation
|
|
实验性的：Planning with patients on ventilation
Planning 4D-CT will be performed with 10 patients (intended for a radiation treatment of their thoracic or upper abdominal tumours) under non-invasive mechanically-assisted ventilation with a respirator.
Different ventilation modes will be compared (spontaneous, physiologic, shallow, slow and jet ventilation).
|
Mechanically ventilation will be done through facial masks connected to a respirator.
Volunteers/patients are fully conscious during the ventilation.
In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
大体时间：within 12 months
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This analysis will be based on dynamic MRI analysis made with healthy volunteers and also patients on non-invasive mechanically assisted ventilation.
A well defined anatomical structure will be selected for the healthy volunteers while the tumor will be tracked in patients.
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within 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tolerance assessment
大体时间：within 12 months
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During all these acquisitions, the tolerance to the non-invasive mechanically assisted ventilation will be assessed by all the participants through a 5-steps scale.
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within 12 months
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Internal motion reproducibility with non-invasive mechanically assisted ventilation.
大体时间：Within 12 months
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This analysis will be done by comparing the motion of the internal structures/tumors at two different time points (MRI acquisition at two different time points).
All these acquisitions will obviously be done in the same conditions on non-invasive mechanically assisted ventilation.
Motion reproducibility will be analysed by comparing the baseline positions of anatomical structures/tumors on MRI images and the measures in millimeters of motion of the same anatomical structures/tumors.
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Within 12 months
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Dosimetric comparison
大体时间：within 12 months
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This dosimetric comparison will be done in order to assess the impact of non-invasive mechanically-assisted ventilation on dose planning and delivery.
Difference in dose (in Gy) to organ at risks will specially be compared through the DVH (dose-volume histogram) analysis.
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within 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xavier Geets, MD, PhD、Cliniques Universitaires Saint-Luc
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月30日
初级完成 (实际的)
2019年6月1日
研究完成 (实际的)
2019年6月1日
研究注册日期
首次提交
2017年6月27日
首先提交符合 QC 标准的
2017年7月20日
首次发布 (实际的)
2017年7月24日
研究记录更新
最后更新发布 (实际的)
2019年7月15日
上次提交的符合 QC 标准的更新
2019年7月12日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.