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

NCT04584086 | Completed

• 1 other identifier: 2020-A02023-36
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Brain Tumors; Proton Therapy

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI 3 Tesla

EXPERIMENTAL

Patients will be followed by 3 Tesla MRIs during the study

Device: MRI 3 tesla

Interventions

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.

MRI 3 Tesla

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre François Baclesse

Caen, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 12, 2020
• Study Start: April 22, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)