Brain NeoplasmsMALTANCT01793714
Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques
An observational study of Brain Neoplasms, run by Rennes University Hospital at 1 site in France.
Trial summary
One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2014to 21 Dec 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Patients with brain tumor involving MRI realization
Who may be able to join
- Patient 18 years and older
- Brain tumor involving frontal and/or temporal lobe and/or insula, with scheduled neurosurgery
- Patient able of accepting protocol information
- Patient who received information about the protocol and had not expressed its opposition to participate
Who cannot join
- Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
- Claustrophobic patient
- Patients who cannot cooperate for the fMRI
- Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.
- Conditions
- Brain Neoplasms
- Keywords
- Magnetic Resonance Imaging
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL)
Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL) to presurgically detect language areas located near a brain tumor
Measured: 2 years
Secondary outcomes (2)
Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL)
Size and location of activations obtained with BOLD fMRI and fASL in the presurgical detection of language areas
Measured: 2 years
Difference of cerebral blood flow maps obtained with ASL and fASL
Cerebral blood flow quantification obtained with standard ASL and extracted from fASL
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start21 Jan 2014
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Ferre, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793714
- Sponsor's protocol ID
- 2012-A00903-40
- Acronym
- MALTA
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2013
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques
- ClinicalTrials.gov ID
- NCT01793714
- Acronym / sponsor ID
- MALTA / 2012-A00903-40
- Conditions
- Brain Neoplasms
- Keywords
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2014 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain tumor involving MRI realization
Key inclusion criteria (4 listed)
- Patient 18 years and older
- Brain tumor involving frontal and/or temporal lobe and/or insula, with scheduled neurosurgery
- Patient able of accepting protocol information
- Patient who received information about the protocol and had not expressed its opposition to participate
Key exclusion criteria (4 listed)
- Patient with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI
- Claustrophobic patient
- Patients who cannot cooperate for the fMRI
- Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL)
Time frame: 2 years
Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL) to presurgically detect language areas located near a brain tumor
2 secondary outcomes
Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL)
Time frame: 2 years
Difference of cerebral blood flow maps obtained with ASL and fASL
Time frame: 2 years
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 11 Mar 2019.
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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.
Jean-Christophe Ferre principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasms, run by Rennes University Hospital 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 4 inclusion and 4 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 11 Mar 2019. 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?
Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL) (time frame: 2 years). 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 11 Mar 2019.