A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain

Recruiting now

Conditions studied: Brain Tumor

In brief

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 have developed a novel automated seed selection method that can accurately map language networks from rs-fMRI. We hypothesize that our innovative approach to enhance, optimize, and validate our preliminary software and integrate it with an established fMRI platform will create robust solutions for clinical RSN and CVR mapping. Partnering with NordicNeuroLab (NNL) will leverage the professional software development by a seasoned commercial MRI software producer in coordination with leading clinical and research experts at MD Anderson. The research will be conducted through three specific aims: 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.

Key facts

Study ID

NCT05342454

Run by

M.D. Anderson Cancer Center

People needed

1720

Starts

2022-05-23

Expected to finish

2026-11-30

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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