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 site in 1 country20 target enrollmentApril 22, 2021

ConditionsBenign Brain Tumors Proton Therapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Benign Brain Tumors
Sponsor: Centre Francois Baclesse
Enrollment: 20
Locations: 1
Primary Endpoint: Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 22, 2021

End Date

February 27, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Francois Baclesse

Responsible Party

Sponsor

Eligibility Criteria

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)