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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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