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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)

Primary Purpose

Benign Brain Tumors, Proton Therapy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI 3 tesla
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Benign Brain Tumors focused on measuring MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Centre François Baclesse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI 3 Tesla

Arm Description

Patients will be followed by 3 Tesla MRIs during the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 1, 2020
Last Updated
March 7, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT04584086
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Brain Tumors, Proton Therapy
Keywords
MRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI 3 Tesla
Arm Type
Experimental
Arm Description
Patients will be followed by 3 Tesla MRIs during the study
Intervention Type
Device
Intervention Name(s)
MRI 3 tesla
Intervention Description
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 Outcome Measure Information:
Title
Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months
Description
modifications of the MRI signal on the various sequences carried out, during the study
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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