NCT05342454

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,720 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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-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

• Brain Tumor

Timeline

• Start date: 2022-05-23
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2022-04-22
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States