Connectome-guided navigation for eloquent-area brain tumor surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled trial compares two surgical planning strategies for brain tumors in language, motor, or major functional areas. The experimental approach uses preoperative diffusion tensor imaging and resting-state fMRI to reconstruct individualized brain networks, which are then integrated with intraoperative guidance and neurophysiological monitoring. The control arm relies on conventional diffusion tensor imaging tractography to guide resection. The primary outcome is postoperative functional preservation, with secondary outcomes including extent of tumor removal and other perioperative measures. Eligible participants have brain tumors near language or motor regions or large functional networks and meet performance status and imaging criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Fengchun Mu
• Email: alicemfc@163.com
• Phone: +8618888294650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.