Can we Use Resting-state fMRI and CSD Fiber Tractography for Presurgical Mapping?

Sponsor
Universitaire Ziekenhuizen KU Leuven (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06040580
Collaborator
(none)
150
1
86.8
1.7

Study Details

Study Description

Brief Summary

This prospective study aims to investigate and validate the use of resting-state functional MRI (rs-fMRI) and high angular resolution diffusion imaging (HARDI), specifically constrained spherical deconvolution (CSD) tractography, for functional and structural brain mapping prior to neurosurgery. The goal is to assess the feasibility of replacing task-based fMRI (tb-fMRI) and diffusion tensor imaging (DTI) with fiber tractography (FT) using the fiber assignment by continuous tracking (FACT) algorithm. The study focuses on mapping sensory-motor, language, visual, and higher cognitive functional and structural networks in patients with brain pathology suitable for surgical intervention. The objective is to improve neurosurgical planning, navigation, and risk assessment through the utilization of rs-fMRI and CSD tractography.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study aims to prospectively investigate and validate the application of resting state functional MRI (rs-fMRI) and High angular resolution diffusion imaging (HARDI), particularly constrained spherical deconvolution (CSD) tractography, in presurgical functional and structural brain mapping for the purposes of neurosurgical planning, navigation and risk assessment. The main objective is to determine whether rs-fMRI and CSD tractography are capable of replacing task based fMRI (tb-fMRI) and diffusion tensor imaging (DTI) based fiber tractography (FT) using the fiber assignment by continuous tracking (FACT) algorithm for mapping the sensory-motor, language, visual, as well as higher cognitive functional and structural networks of the brain in patients with brain pathology amenable for surgical intervention. This research question will be investigated by acquiring tb-fMRI and rs-fMRI, as well as HARDI data for presurgical patients. The routine workflow of presurgical planning and risk assessment using tb-fMRI and DTI FT will be followed and used for the initial planning. Previous studies have revealed a high degree of concordance between rs-fMRI and tb-fMRI[1]-[5] as well as between CSD and DTI FT[6]-[8], but drew such conclusions from relatively small sample sizes. The aim is to incorporate the rs-fMRI and CSD results into the presurgical planning process albeit with more weight assigned to the tb-fMRI and DTI results. The study population will consist of 10 normal controls for MR imaging optimization purposes only, 150 presurgical patients from the UZ Leuven imaging department regardless of the exact type of pathology (space occupying lesions, epilepsy, vascular malformations etc.).

    As tb-fMRI has previously been validated versus the gold standard of functional mapping, electrical cortical stimulation (ECS), while rs-fMRI has previously been validated against tb-fMRI. The same has been done comparing DTI and CSD. To our knowledge however, a comparative study with such a large and diverse study population attempting to cross validate all these modalities against the gold standard has not yet been done.

    Image acquisition acceleration methods, such as parallel imaging (PI), simultaneous multislice acquisitions (SMS) and compressed sensing (CS) will be used whenever feasible. These acceleration methods can potentially be exploited to improve fMRI, and dMRI data quality as well as shorten acquisition time. In the case of fMRI, PI and SMS can be used to increase temporal resolution, temporal signal to noise ratio and even spatial resolution. dMRI stands to benefit from such techniques by increasing directional and/or spatial resolution.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Use of Resting State fMRI and CSD Tractography for Pre-operative Brain Mapping: a Cross-sectional Study
    Actual Study Start Date :
    Oct 8, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

    Preoperative patients in need of brain surgery for varying brain pathology who require presurgical brain mapping with MRI (fMRI, and dMRI)

    Outcome Measures

    Primary Outcome Measures

    1. Differences in accuracy between CSD and DTI fiber tractography as well as resting-state and task-based fMRI [Through phase 1 recruitment completion (about 2 years from start of recruitment)]

      A comparative analysis examining differences in accuracy measures between different fMRI and dMRI tractography methods, namely resting-state fMRI v. task-based fMRI and DTI v CSD diffusion tractography using intraoperative direct electrical stimulation results as the ground truth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Stable clinical condition

    • Cooperative and able to perform the fMRI tasks in question

    • In need of preoperative MRI mapping scans

    Exclusion Criteria:
    • Absolute contraindications to MRI

    • Previously underwent resective brain surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen KU Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof dr Stefan Sunaert, Principal Investigator, Universitaire Ziekenhuizen KU Leuven
    ClinicalTrials.gov Identifier:
    NCT06040580
    Other Study ID Numbers:
    • S61759
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 15, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Prof dr Stefan Sunaert, Principal Investigator, Universitaire Ziekenhuizen KU Leuven
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 15, 2023