Actively Recruiting
A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
1720
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new clinical fMRI software designed to map critical brain functional networks and cerebrovascular reactivity in patients with brain tumors. The goal is to improve presurgical planning by integrating resting-state fMRI (rs-fMRI), task-based fMRI (tb-fMRI), and cerebrovascular reactivity (CVR) mapping. This observational study aims to validate the accuracy of rs-fMRI compared to tb-fMRI using intra-operative direct cortical stimulation as the gold standard, and to test whether CVR mapping enhances confidence in identifying important brain areas. The study involves developing and optimizing software to map resting-state networks and CVR, then testing its use in patients undergoing neurosurgical tumor removal. The research includes retrospective review of prior clinical presurgical fMRI studies and a prospective phase where patients will have presurgical fMRI and direct cortical stimulation as part of their standard care. The software development will be done in partnership with a commercial MRI software producer to create robust clinical tools. Participants will undergo presurgical fMRI scans, including resting-state and task-based imaging, as part of their usual care, followed by direct cortical stimulation during surgery. Researchers will analyze these imaging data to validate the software's mapping accuracy. The primary outcome is to confirm the ability of rs-fMRI to identify language and motor areas reliably. The study will continue through to completion, averaging about one year per participant, with no investigational treatments given, focusing on imaging and surgical assessments.
CONDITIONS
Brief Title
A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older
- Patients scheduled for neurosurgical removal of brain tumors
- Patients who will have presurgical fMRI as part of standard care
- Patients who will undergo direct cortical stimulation during neurosurgery as standard care
- For retrospective review, patients must be 18 years or older and have had presurgical fMRI with at least one task-based scan
You will not qualify if you...
- Patients unable to give informed consent
- Patients unable to undergo MRI examinations
- Patients indicated for speech fMRI only who cannot perform speech tasks based on neuropsychologist evaluation
- Retrospective scans contaminated by head motion exceeding 2 mm translation or 2 degrees rotation
- Retrospective cases with only speech fMRI paradigms where patients could not comply with speech tasks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo resting-state and task-based fMRI mapping using the software developed in this research, as well as presurgical fMRI as part of standard care.
1 to 2 visits depending on clinical scheduling
Duration - Up to 1 year
Participants are observed through intra-operative direct cortical stimulation during neurosurgery and the accuracy of fMRI mapping is assessed.
Visits aligned with standard surgical and follow-up care
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Ho-Ling Liu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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