CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial

NCT07657403 · tracked via the Priya Life Science China tracker

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Not applicable

Started

2025-11-01

Last updated

2026-06-18

Condition(s) studied

Brain NeoplasmsEloquent Area Brain Tumors

Investigational drug(s) / intervention(s)

Connectome-Guided Navigation-Assisted Microsurgical ResectionConventional DTI Tractography-Guided Tumor Resection

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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. 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. 2. Karnofsky Performance Status (KPS) score of 70 or higher. 3. Preoperative MRI demonstrating a spatial relationship between the tumor and major white matter tracts, such as the corticospinal tract or arcuate fasciculus. 4. No other neurological disease or underlying condition that may cause neurological dysfunction. 5. No prior treatment for a brain tumor in the same region, such as radiotherapy. 6. Tumor not extensively adherent to multiple critical network nodes. 7. Planned craniotomy for tumor resection and provision of written informed consent by the patient or legally authorized representative. Exclusion Criteria: 1. Pathologically or clinically suspected non-neoplastic brain lesion. 2. Multifocal tumors. 3. Incomplete evaluation data. 4. Withdrawal from the study by the patient or legally authorized representative for any reason. 5. Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.

Primary outcome measure(s)

Postoperative Functional Preservation Rate — 6 months after surgery
The proportion of participants with preservation of neurological function at 6 months after surgery compared with baseline, based on neurological examination and protocol-specified functional assessments.

Trial sites (1)

Facility	City	Region	Status
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07657403 on ClinicalTrials.gov ↗ ← All trials in China