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

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ClinicalTrials.gov Identifier: NCT01793714
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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
Brain Neoplasms

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Study Type : Observational [Patient Registry]
Actual Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques
Actual Study Start Date : January 21, 2014
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL) [ Time Frame: 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 [ Time Frame: 2 years ]
    Cerebral blood flow quantification obtained with standard ASL and extracted from fASL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain tumor involving MRI realization
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793714


Locations
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France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Jean-Christophe Ferre Rennes University Hospital

Additional Information:

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01793714    
Other Study ID Numbers: 2012-A00903-40
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Keywords provided by Rennes University Hospital:
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases