Added Value of Mechanically-assisted Ventilation in the Treatment of Moving Tumours (Thoracic/Upper Abdomen) With Photon and Proton Therapies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •No comorbidity for healthy volunteers
- •Cancer patients with either lung or upper abdomen (liver/pancreas) tumours treated with radiation therapy.
排除标准
- •severe lung disease or emphysema
- •previous history of pneumothorax
- •claustrophobia
结局指标
主要结局
Measure in millimeters of the internal motion during non-invasive mechanically assisted ventilation, based on MRI images
时间窗: within 12 months
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.
次要结局
- Dosimetric comparison(within 12 months)
- Tolerance assessment(within 12 months)
- Internal motion reproducibility with non-invasive mechanically assisted ventilation.(Within 12 months)