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)

January 5, 2023 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Centre François Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI 3 Tesla
Patients will be followed by 3 Tesla MRIs during the study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02023-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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