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

Proton Therapy Clinical Trial

— BRAIN TEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584086
• Other study ID #: 2020-A02023-36
• Status: Completed
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: March 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Brain Tumors
• Brain Neoplasms
• Proton Therapy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months	modifications of the MRI signal on the various sequences carried out, during the study	Up to 6 months