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

March 8, 2019 updated by: Rennes University Hospital

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 Overview

Status

Completed

Conditions

Brain Neoplasms

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Rennes, France, 35033
    - Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with brain tumor involving MRI realization

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 years
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	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

Principal Investigator: Jean-Christophe Ferre, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2014

Primary Completion (ACTUAL)

December 21, 2017

Study Completion (ACTUAL)

December 21, 2017

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria