About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
all fMRI scans were contaminated by head motions (translation > 2 mm or rotation > 2 degrees);
Trial population
For the prospective study we will include 120 patients with brain tumors. 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.
Trial design
Case-only
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Validate resting-state fMRI (rs-fMRI) mapping of language and motor (hand and tongue) areas obtained by using the software developed in this research.
Sponsors and contacts
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