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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04584086
Acronym
BRAIN TEL
Enrollment
20
Registered
2020-10-12
Start date
2021-04-22
Completion date
2023-02-27
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Brain Tumors, Proton Therapy

Keywords

MRI

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.

Interventions

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.

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 monthsUp to 6 monthsmodifications of the MRI signal on the various sequences carried out, during the study

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026