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

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.

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Key information

Conditions

Benign Brain Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Proton Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI 3 tesla

Device

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.

Primary outcomes

Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months

Time frame: Up to 6 months

modifications of the MRI signal on the various sequences carried out, during the study

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: BRAIN TEL

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Oct 12, 2020
Registry last updated: Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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