A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain
NCT ID: NCT05342454
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1720 participants
OBSERVATIONAL
2022-05-23
2026-11-30
Brief Summary
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1. Develop a clinical software platform for mapping RSNs and determine optimized workflow for presurgical localization of eloquent areas.
2. Develop a clinical software platform for mapping CVR and determine optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results.
3. Test and validate RSN and CVR mapping software in patients undergoing neurosurgery.
Detailed Description
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To validate resting-state fMRI (rs-fMRI) mapping of language and motor (hand and tongue) areas obtained by using the software developed in this research: We will test the non-inferiority of rs-fMRI comparing to task-based fMRI (tb-fMRI) by using intra-operative direct cortical stimulation as the gold standard.
To test whether CVR mapping using the software developed in this research will increase confidence of fMRI mapping of language and motor (hand and tongue) areas: We will test whether the accuracy of fMRI, assessed by using intra-operative direct cortical stimulation as the gold standard, will improve after incorporating the CVR mapping.
Secondary Objectives:
To optimize the rs-fMRI and CVR mapping software during the development phases and to test feasibility of the post-processing workflow using clinical images.
Conditions
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Study Design
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CASE_ONLY
OTHER
Eligibility Criteria
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Inclusion Criteria
2. patients who will undergo neurosurgical resection of brain tumors;
3. patients who will undergo presurgical fMRI as standard of care;
4. patients who on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care.
For the retrospective study, we will review up to 1600 patients all clinical presurgical fMRI studies performed on brain tumor patients at the MD Anderson since 5/2004.
1. patients must be \>/= 18 years of age;
2. patients who had the presurgical fMRI that contained at least one task-based fMRI scan.
Exclusion Criteria
2. patients cannot undergo MRI examinations;
3. patients who are indicated for speech fMRI only but cannot comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.
1. all fMRI scans were contaminated by head motions (translation \> 2 mm or rotation \> 2 degrees);
2. only speech fMRI paradigms were performed, and patients were not able to comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ho-Ling Liu, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ho-Ling Liu, PhD
Role: primary
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2022-00369
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0791
Identifier Type: -
Identifier Source: org_study_id