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Clinical Trials/NCT01793714
NCT01793714CompletedNot Applicable

Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques

Rennes University Hospital1 site in 1 country34 target enrollmentStarted: January 21, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL)

Study Overview

Brief 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. 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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL)(2 years)
  • Difference of cerebral blood flow maps obtained with ASL and fASL(2 years)

Investigators

Sponsor
Rennes University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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