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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 (BRAIN TEL)

C

Centre Francois Baclesse

Status

Completed

Conditions

Benign Brain Tumors
Proton Therapy

Treatments

Device: MRI 3 tesla

Study type

Interventional

Funder types

Other

Identifiers

NCT04584086
2020-A02023-36

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

MRI 3 Tesla
Experimental group
Description:
Patients will be followed by 3 Tesla MRIs during the study
Treatment:
Device: MRI 3 tesla

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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