Proton Therapy Clinical Trial
— BRAIN TELOfficial title:
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
Verified date | March 2023 |
Source | Centre Francois Baclesse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 27, 2023 |
Est. primary completion date | February 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Centre François Baclesse | Caen |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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