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

Brain Neoplasms Clinical Trial

— MALTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793714
• Other study ID #: 2012-A00903-40
• Status: Completed
• Start date: January 21, 2014
• Est. completion date: December 21, 2017

Study information

• Verified date: March 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Langage laterality index obtained with both techniques (BOLD fMRI and fASL)and fASL)	Size and location of activations obtained with BOLD fMRI and fASL in the presurgical detection of language areas	2 years
Secondary	Difference of cerebral blood flow maps obtained with ASL and fASL	Cerebral blood flow quantification obtained with standard ASL and extracted from fASL	2 years