Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With P… (NCT04584086) | Clinical Trial Compass
CompletedNot Applicable
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
France20 participantsStarted 2021-04-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months