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CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.
Official title: A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-11-01
Completion Date
2028-12-31
Last Updated
2026-06-18
Healthy Volunteers
No
Interventions
Connectome-Guided Navigation-Assisted Microsurgical Resection
Microsurgical resection of eloquent-area brain tumors guided by preoperative diffusion tensor imaging and resting-state functional MRI-based brain network reconstruction. The intervention integrates connectome-informed surgical planning, intraoperative neuronavigation, and neurophysiological monitoring to define individualized resection boundaries with the goal of maximizing tumor removal while preserving neurological function.
Conventional DTI Tractography-Guided Tumor Resection
Microsurgical resection of eloquent-area brain tumors guided by conventional diffusion tensor imaging tractography-assisted navigation according to standard surgical planning procedures. This intervention serves as the comparator for evaluation of postoperative functional preservation, extent of resection, and other clinical outcomes.
Locations (1)
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China