Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine).
研究概览
简要总结
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).
After signing the consent form, each patient will be randomized to one of two treatment arms:
- Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
- Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.
详细描述
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).
After signing the consent form, each patient will be randomized to one of two treatment arms:
- Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
- Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen
The aim is to compare the effect of the non-magnetic screen on the blocking of the patient's breathing versus the current procedure (the blocking of the breathing is informed by the staff)
The patients will each receive 5 sessions of radiotherapy on Linac MRI. 100 patients are expected to participate in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years old
- •Patient starting radiotherapy on Linac MRI for a mobile cancerous lesion most often in the pancreas, liver, kidneys, adrenals, lung, supra or subdiaphragmatic adenopathy
- •Patient affiliated to the social security system
排除标准
- •Patient with lesions not detected by the device's tracking system
- •Patient with visual disturbances
- •Contraindications to treatment with Linac MRI (epileptic patients, pregnant or breastfeeding women, metallic prosthesis or pacemaker not compatible with MRI)
- •Patients with cognitive disorders
- •Persons deprived of liberty or under guardianship (including curatorship)
- •Pregnant or nursing woman
- •Refusal to participate in the study
结局指标
主要结局
The effect of the non-magnetic screen during radiotherapy (Change in ratio of actual treatment time to the treatment time predicted by the machine).
时间窗: During 25 months
To evaluate the effect of a non-magnetic screen visible to the patient in the bunker during radiation therapy sessions delivered by Linac MRI on decreasing the ratio of actual treatment time to the treatment time predicted by the machine.
次要结局
- Patient respiratory effort with visual analog scale(During 25 months)
- The potential time(During 25 months)
- The patient satisfaction evaluated with an ad-hoc questionnaire.(During 25 months)
- The positional pain with visual analog scale(During 25 months)
- Level of anxiety/stress evaluated with the Spielberg scale via the STAI-Y-form grid(During 25 months)