NCT07657403 CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial

Eligibility & Interventions

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This trial targets 200 participants in total. It began in 2025-11-01 with a primary completion date of 2027-12-31.

Brief 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 Criteria

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.

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