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

NCT01793714 | Completed DMC

• 1 other identifier: 2012-A00903-40
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms

Keywords

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Qualitative and quantitative comparison of brain activations obtained with both techniques (BOLD fMRI and fASL)

  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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with brain tumor involving MRI realization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean-Christophe Ferre

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: January 21, 2014
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

FR (1)