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

• ClinicalTrials.gov Identifier: NCT06040580
• Recruitment Status: Active, not recruiting
• First Posted: September 15, 2023
• Last Update Posted: September 15, 2023
• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Information provided by (Responsible Party): Prof dr Stefan Sunaert, Universitaire Ziekenhuizen KU Leuven

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
Brain Tumor; Brain Pathology; Epilepsy; Vascular Malformations, Brain

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
• Estimated 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: October 8, 2018
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2025

Groups and Cohorts

Group/Cohort
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 [ Time Frame: 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

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients with any brain pathology amenable to surgery who have not undergone previous resective surgery, regardless of age, gender or type of disease.

Healthy volunteers are only included for scan optimization puproses.

Criteria

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

Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven

More Information

Publications of Results:

Radwan AM, Emsell L, Blommaert J, Zhylka A, Kovacs S, Theys T, Sollmann N, Dupont P, Sunaert S. Virtual brain grafting: Enabling whole brain parcellation in the presence of large lesions. Neuroimage. 2021 Apr 1;229:117731. doi: 10.1016/j.neuroimage.2021.117731. Epub 2021 Jan 14.

Other Publications:

Radwan AM, Sunaert S, Schilling K, Descoteaux M, Landman BA, Vandenbulcke M, Theys T, Dupont P, Emsell L. An atlas of white matter anatomy, its variability, and reproducibility based on constrained spherical deconvolution of diffusion MRI. Neuroimage. 2022 Jul 1;254:119029. doi: 10.1016/j.neuroimage.2022.119029. Epub 2022 Feb 26.

• Responsible Party: Prof dr Stefan Sunaert, Principal Investigator, Universitaire Ziekenhuizen KU Leuven
• ClinicalTrials.gov Identifier: NCT06040580
• Other Study ID Numbers: S61759
• First Posted: September 15, 2023
• Last Update Posted: September 15, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Anonymized and coded data may be shared with other research groups upon reasonable request to the authors.

• 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, Universitaire Ziekenhuizen KU Leuven:

Functional MRI; Diffusion MRI; Fiber Tractography; Preoperative brain mapping

Additional relevant MeSH terms:

Central Nervous System Vascular Malformations; Vascular Malformations; Nervous System Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Cardiovascular Diseases; Nervous System Malformations