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OpenTrials
Completed

NCT Number: NCT01793714

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MALTA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2013
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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