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

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01793714
Collaborator
(none)
34
Enrollment
1
Location
47
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    34 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques
    Actual Study Start Date :
    Jan 21, 2014
    Actual Primary Completion Date :
    Dec 21, 2017
    Actual Study Completion Date :
    Dec 21, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL) [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 Outcome Measures

    1. Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL) [2 years]

      Size and location of activations obtained with BOLD fMRI and fASL in the presurgical detection of language areas

    2. Difference of cerebral blood flow maps obtained with ASL and fASL [2 years]

      Cerebral blood flow quantification obtained with standard ASL and extracted from fASL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rennes University Hospital Rennes France 35033

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Jean-Christophe Ferre, Rennes University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01793714
    Other Study ID Numbers:
    • 2012-A00903-40
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Mar 11, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by Rennes University Hospital
    Magnetic Resonance Imaging
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Mar 11, 2019