CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial

NCT07657403 | Recruiting

• 2 other identifiers: NCC-0200192024-I2M-3-014
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms; Eloquent Area Brain Tumors

Keywords

Connectome-guided surgery; Eloquent area brain tumor; Brain network navigation; Diffusion tensor imaging; DTI tractography; Resting-state fMRI; Functional preservation; Microsurgical resection; Intraoperative neurophysiological monitoring

Outcome Measures

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.

  6 months after surgery

Secondary Outcomes (2)

• Extent of Resection

  Within 24 to 72 hours after surgery

• Incidence of Postoperative Complications

  Within 30 days after surgery

Study Arms (2)

Connectome-Guided Surgery Group

EXPERIMENTAL

Participants in this arm will undergo connectome-guided navigation-assisted microsurgical resection. The surgical strategy includes preoperative diffusion tensor imaging and resting-state functional MRI-based brain network reconstruction, integrated with intraoperative neuronavigation and neurophysiological monitoring to guide resection boundaries and optimize postoperative functional preservation.

Procedure: Connectome-Guided Navigation-Assisted Microsurgical Resection

Conventional Tractography-Guided Surgery Group

ACTIVE COMPARATOR

Participants in this arm will undergo conventional DTI tractography-guided microsurgical resection using standard surgical planning and navigation procedures. This group serves as the comparator for evaluating postoperative functional preservation and extent of resection.

Procedure: Conventional DTI Tractography-Guided Tumor Resection

Interventions

Connectome-Guided Navigation-Assisted Microsurgical Resection PROCEDURE

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.

Also known as: Brain network-guided surgery, Connectome-guided surgery, DTI and rs-fMRI-guided tumor resection

Connectome-Guided Surgery Group

Conventional DTI Tractography-Guided Tumor Resection PROCEDURE

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.

Also known as: Conventional tractography-guided surgery, DTI-guided microsurgical resection, Standard tractography-assisted tumor resection

Conventional Tractography-Guided Surgery Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Fengchun Mu

CONTACT

+8618888294650; alicemfc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Blinding of participants and treating surgeons is not feasible because of the nature of the surgical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups. The experimental group will undergo connectome-guided navigation-assisted microsurgical resection based on preoperative DTI and resting-state fMRI brain network reconstruction combined with intraoperative navigation and neurophysiological monitoring. The control group will undergo conventional DTI tractography-guided tumor resection.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 18, 2026

Record last verified: 2025-11

Locations

CN (1)