Status:
RECRUITING
A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Brain Tumor
Eligibility:
All Genders
18+ years
Brief Summary
Our preliminary work demonstrates that an integrated fMRI software solution, incorporating tb-fMRI, rs-fMRI, and CVR mapping, is clinically feasible and helps clinicians plan brain tumor resection. We...
Detailed Description
Primary Objectives: 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-infe...
Eligibility Criteria
Inclusion criteria:
- patient must be >/= 18 years of age;
- patients who will undergo neurosurgical resection of brain tumors;
- patients who will undergo presurgical fMRI as standard of care;
- 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.
The inclusion criteria:
- patients must be >/= 18 years of age;
- patients who had the presurgical fMRI that contained at least one task-based fMRI scan.
Exclusion Criteria:
Exclusion criteria for the prospective study:
- patients cannot give informed consent;
- patients cannot undergo MRI examinations;
- 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.
Exclusion criteria for the retrospective study:
- all fMRI scans were contaminated by head motions (translation > 2 mm or rotation > 2 degrees);
- 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.
Key Trial Info
Start Date :
May 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
1720 Patients enrolled
Trial Details
Trial ID
NCT05342454
Start Date
May 23 2022
End Date
November 30 2026
Last Update
November 14 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030