CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial (NCT07657403) | Clinical Trial Compass
RecruitingNot Applicable
CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial
China200 participantsStarted 2025-11-01
Plain-language summary
This study is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery than conventional tractography-guided surgery.
Participants who meet the study criteria will be assigned to one of two surgical planning strategies. In the experimental group, patients will undergo preoperative diffusion tensor imaging and resting-state functional MRI for individualized brain network reconstruction, and these data will be integrated with intraoperative navigation and neurophysiological monitoring to guide the resection boundary. In the control group, surgery will be guided by conventional DTI tractography-assisted navigation.
The main outcome is the rate of postoperative functional preservation. Other outcomes include extent of tumor resection, postoperative complications, time to neurological recovery, overall survival, and quality of life. Patients will be evaluated before surgery and followed after surgery with clinical examinations, neurological assessments, and MRI at prespecified time points.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients clinically diagnosed with brain tumors involving language areas, motor areas, or major functional brain networks, including the default mode network, central executive network, dorsal attention network, or ventral attention network.
. Karnofsky Performance Status (KPS) score of 70 or higher.
. Preoperative MRI demonstrating a spatial relationship between the tumor and major white matter tracts, such as the corticospinal tract or arcuate fasciculus.
. No other neurological disease or underlying condition that may cause neurological dysfunction.
. No prior treatment for a brain tumor in the same region, such as radiotherapy.
. Tumor not extensively adherent to multiple critical network nodes.
. Planned craniotomy for tumor resection and provision of written informed consent by the patient or legally authorized representative.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Functional Preservation Rate
Timeframe: 6 months after surgery
Trial details
NCT IDNCT07657403
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences