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

NCT06040580 | Unknown

• 1 other identifier: S61759
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Differences in accuracy between CSD and DTI fiber tractography as well as resting-state and task-based fMRI

  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

  Through phase 1 recruitment completion (about 2 years from start of recruitment)

Study Arms (1)

Patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Stable clinical condition
• Cooperative and able to perform the fMRI tasks in question
• In need of preoperative MRI mapping scans

You may not qualify if:

• Absolute contraindications to MRI
• Previously underwent resective brain surgery

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 35231632 BACKGROUND

• 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.

  PMID: 33454411 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Epilepsy; Central Nervous System Vascular Malformations

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: September 15, 2023
• Study Start: October 8, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)