CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pathologically or clinically suspected non-neoplastic brain lesion.
Multifocal tumors.
Incomplete evaluation data.
Withdrawal from the study by the patient or legally authorized representative for any reason.
Trial design
Design model
Parallel
Treatments tested in this trial
Connectome-Guided Navigation-Assisted Microsurgical Resection
Procedure/SurgeryMicrosurgical 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
Procedure/SurgeryMicrosurgical 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Connectome-Guided Surgery GroupExperimental treatment 1 intervention
Group B: Conventional Tractography-Guided Surgery GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Functional Preservation Rate
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.
Time frame
6 months after surgerySecondary outcomes
1
Extent of Resection
Extent of tumor resection assessed on postoperative contrast-enhanced brain MRI performed within 24 to 72 hours after surgery.
Time frame
Within 24 to 72 hours after surgery2
Incidence of Postoperative Complications
The incidence of surgery-related postoperative complications, including new or worsened neurological deficits, intracranial hemorrhage, brain edema, seizures, intracranial infection, deep vein thrombosis, and other protocol-defined adverse events.
Time frame
Within 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov