Can we Use Resting-state fMRI and CSD Fiber Tractography for Presurgical Mapping?
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06040580 |
Recruitment Status :
Active, not recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Brain Tumor Brain Pathology Epilepsy Vascular Malformations, Brain |
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 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 |
Group/Cohort |
---|
Patients
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 [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040580
Belgium | |
UZ Leuven | |
Leuven, Vlaams Brabant, Belgium, 3000 |
Other Publications:
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 Key Record Dates |
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 |
Functional MRI Diffusion MRI Fiber Tractography Preoperative brain mapping |
Central Nervous System Vascular Malformations Vascular Malformations Nervous System Diseases Congenital Abnormalities |
Cardiovascular Abnormalities Cardiovascular Diseases Nervous System Malformations |