NCT05342454 A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain
| NCT ID | NCT05342454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Brain Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,720 participants |
| Start Date | 2022-05-23 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,720 participants in total. It began in 2022-05-23 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Ho-Ling Liu, PhD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05342454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05342454 currently recruiting?
Yes, NCT05342454 is actively recruiting participants. Contact the research team at hlaliu@mdanderson.org for enrollment information.
Where is the NCT05342454 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05342454 clinical trial?
NCT05342454 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ho-Ling Liu, PhD at M.D. Anderson Cancer Center. The trial plans to enroll 1,720 participants.