NCT04584086已完成不适用
Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received
Centre Francois Baclesse1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年4月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months
研究概览
简要总结
The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.
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
- 否
入选标准
- •Histologically proven or highly probable grade I meningiomas, histologically proven grade II meningiomas.
- •Only meningiomas of the anterior and middle floors of the base of the skull are included.
- •Indication of proton therapy retained in RCP and / or proton therapy technical staff (Caen site)
- •Patient aged 18 or over
- •Patient affiliated to a social security scheme
- •Signature of informed consent before any specific procedure related to the study
排除标准
- •History of brain or face irradiation.
- •Implant or foreign body that can alter MRI imaging.
- •Contraindication to MRI (pace maker, claustrophobia ...) - Hypersensitivity to gadoteric acid, to meglumine or to any medicine containing gadolinium
- •Genetic radio sensitizing syndrome
- •Known neurological comorbidities (stroke, Parkinson's, etc.) that may impact MRI data.
- •Simultaneous participation in a therapeutic clinical trial
- •Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons
- •Pregnant or breastfeeding women
- •Persons deprived of their liberty (see article L 1121-6 CSP),
- •Adults who are the subject of a legal protection measure or unable to express their consent (see article L 1121-8)
结局指标
主要结局
Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months
时间窗: Up to 6 months
modifications of the MRI signal on the various sequences carried out, during the study
次要结局
未报告次要终点
研究者
研究点 (1)
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