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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Benign Brain Tumors, Proton Therapy

Intervention / Treatment
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* Device: MRI 3 tesla


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI 3 Tesla<br>Patients will be followed by 3 Tesla MRIs during the study | Device: MRI 3 tesla<br>* 1.5 Tesla MRIs, usually used as pre-treatment and, between 3 and 6 months after irradiation, are replaced in the study by 3 Tesla MRIs (pre-treatment and at 6 months) In addition, two additional MRIs, also performed with a 3 Tesla magnetic field, will be performed: During treatment when half of the prescribed dose has been delivered. 1 month after the end of the irradiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months | modifications of the MRI signal on the various sequences carried out, during the study | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI