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

Not Applicable

Completed

• Conditions: Proton Therapy; Benign Brain Tumors

• Registration Number: NCT04584086
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-12
• Study Start: 2021-04-22
• Primary Completion: 2023-02-27
• Study Completion: 2023-02-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months	Up to 6 months	modifications of the MRI signal on the various sequences carried out, during the study

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, France