Clinical trial · Interventional
CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial
A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Eloquent Area Brain Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Connectome-Guided Navigation-Assisted Microsurgical Resection | Procedure | — | UNRESOLVED |
| Conventional DTI Tractography-Guided Tumor Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Connectome-Guided Surgery Group
- description
- 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.
- interventionNames
- Procedure: Connectome-Guided Navigation-Assisted Microsurgical Resection
- type
- ACTIVE_COMPARATOR
- label
- Conventional Tractography-Guided Surgery Group
- description
- 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.
- interventionNames
- Procedure: Conventional DTI Tractography-Guided Tumor Resection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available