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
- 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.
Exclusion
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