An observational study in Brain Tumor, Brain Pathology and Epilepsy, sponsored by Universitaire Ziekenhuizen KU Leuven. Active, not recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
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.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 150 is above the median of 99 across 433 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Preoperative patients in need of brain surgery for varying brain pathology who require presurgical brain mapping with MRI (fMRI, and dMRI)
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
Time frame: Through phase 1 recruitment completion (about 2 years from start of recruitment)
Plan to share: No — Anonymized and coded data may be shared with other research groups upon reasonable request to the authors.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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