Benign Brain TumorsBRAIN TELNCT04584086
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
A study testing MRI 3 tesla in people with Benign Brain Tumors and Proton Therapy, run by Centre Francois Baclesse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Brain Tumors, Proton Therapy
- What is being tested?
- MRI 3 tesla
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 27 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- MRI 3 tesla
- Keywords
- MRI
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 3 teslaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI 3 Tesla | Experimental | Patients will be followed by 3 Tesla MRIs during the study Receives: Device: MRI 3 tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start22 Apr 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Brain TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584086
- Sponsor's protocol ID
- 2020-A02023-36
- Acronym
- BRAIN TEL
- Status last verified
- Mar 2023
- First submitted
- 1 Oct 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04584086
- Acronym / sponsor ID
- BRAIN TEL / 2020-A02023-36
- Conditions
- Benign Brain Tumors, Proton Therapy
- Keywords
- MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI 3 Tesla | Experimental | Device: MRI 3 teslaPatients will be followed by 3 Tesla MRIs during the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI 3 tesla1.5 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. | Device | MRI 3 Tesla |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI 3 tesla in people with Benign Brain Tumors and Proton Therapy, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.