Mapping brain networks and blood flow for brain tumor surgery

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

This study is testing a new brain imaging software to see if it can help plan safer brain tumor surgeries by mapping important brain networks better than traditional methods.

Quick facts

• Study type: Observational
• Enrollment: 1720 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05342454 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop and validate a comprehensive fMRI software solution that integrates resting-state fMRI (rs-fMRI) and cerebrovascular reactivity (CVR) mapping to assist in the presurgical planning of brain tumor resections. The study will compare the effectiveness of rs-fMRI against traditional task-based fMRI using intra-operative direct cortical stimulation as a benchmark. Additionally, the research will optimize the software for clinical use and assess its feasibility in mapping critical functional networks in the brain. The collaboration with NordicNeuroLab will enhance the software's development, ensuring it meets clinical standards.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are scheduled for neurosurgical resection of brain tumors and will undergo presurgical fMRI.

Not a fit: Patients who cannot undergo MRI examinations or those who are only indicated for speech fMRI without the ability to comply with speech tasks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the accuracy of brain tumor surgeries by providing better mapping of critical brain functions.

How similar studies have performed: Previous studies have shown promise in using fMRI for brain mapping, but this specific integrated approach is novel and has not been extensively tested.

Eligibility criteria

Inclusion criteria:

1. patient must be \>/= 18 years of age;
2. patients who will undergo neurosurgical resection of brain tumors;
3. patients who will undergo presurgical fMRI as standard of care;
4. 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:

1. patients must be \>/= 18 years of age;
2. patients who had the presurgical fMRI that contained at least one task-based fMRI scan.

Exclusion Criteria:

Exclusion criteria for the prospective study:

1. patients cannot give informed consent;
2. patients cannot undergo MRI examinations;
3. 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:

1. all fMRI scans were contaminated by head motions (translation \> 2 mm or rotation \> 2 degrees);
2. 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 this trial is running

Houston, Texas

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

Study contacts

• Principal investigator: Ho-Ling Liu, PhD — M.D. Anderson Cancer Center
• Study coordinator: Ho-Ling Liu, PhD

Conditions Brain Tumor