New brain mapping software could make tumor surgery safer
NCT ID NCT05342454
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new computer program that helps doctors see which parts of the brain control important functions like language and movement. The goal is to help surgeons plan brain tumor removal more safely. About 1,720 adults with brain tumors who need surgery will take part. The software uses special MRI scans to create detailed maps of the brain.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,720 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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