Clinical trial · Interventional
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
NCT04584086CI-TRIAL-00064547BRAIN TELcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Brain Tumors | Benign Brain Neoplasm | ALIAS | 0.90 |
| Proton Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI 3 tesla | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI 3 Tesla
- description
- Patients will be followed by 3 Tesla MRIs during the study
- interventionNames
- Device: MRI 3 tesla
Primary outcomes (1)
- measure
- Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months
- timeFrame
- Up to 6 months
- description
- modifications of the MRI signal on the various sequences carried out, during the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.