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
NCT ID: NCT04584086
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-04-22
2023-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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MRI 3 Tesla
Patients will be followed by 3 Tesla MRIs during the study
MRI 3 tesla
1.5 Tesla MRIs, usually used as pre-treatment and, between 3 and 6 months after irradiation, are replaced in the study by 3 Tesla MRIs (pre-treatment and at 6 months)
In addition, two additional MRIs, also performed with a 3 Tesla magnetic field, will be performed:
* During treatment when half of the prescribed dose has been delivered.
* 1 month after the end of the irradiation.
Interventions
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MRI 3 tesla
1.5 Tesla MRIs, usually used as pre-treatment and, between 3 and 6 months after irradiation, are replaced in the study by 3 Tesla MRIs (pre-treatment and at 6 months)
In addition, two additional MRIs, also performed with a 3 Tesla magnetic field, will be performed:
* During treatment when half of the prescribed dose has been delivered.
* 1 month after the end of the irradiation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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Centre François Baclesse
Caen, , France
Countries
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Other Identifiers
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2020-A02023-36
Identifier Type: -
Identifier Source: org_study_id
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