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Non-Helium Magnetoencephalography in Pediatric Brain Tumors

Non-Helium Magnetoencephalography for Clinical Management of Pediatric Brain Tumors : An Observational Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06943742
Enrollment
100
Registered
2025-04-24
Start date
2024-11-05
Completion date
2027-12-31
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Brain Tumor

Keywords

Magnetoencephalography, Pediatric Brain Tumor

Brief summary

This observational study aims to evaluate the effectiveness of magnetoencephalography (MEG) in the preoperative assessment of pediatric brain tumors, particularly in determining the extent of resection, and compare it with computed tomography (CT) and magnetic resonance imaging (MRI). The main questions this study aims to answer are: What is the consistency between MEG and CT/MRI in localizing pediatric brain tumors? What is the clinical efficacy of MEG in determining the extent of resection of pediatric brain tumors preoperatively? Participants will: Undergo both MEG and CT/MRI examinations for preoperative assessment, and the extent of tumor resection will be determined by the comprehensive results of the above examinations. Be followed up with MEG and CT/MRI at 1, 3, and 6 months after surgery, along with neurological and quality-of-life assessments.

Interventions

DIAGNOSTIC_TESTMagnetoencephalography plus Computed Tomography/Magnetic Resonance Imaging

Use Magnetoencephalography and Computed Tomography/Magnetic Resonance Imaging in the preoperative assessment of pediatric brain tumors.

Sponsors

Beijing X-Magtech Technology Limited
CollaboratorUNKNOWN
Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Age range: 3-18 years old; * Clinically diagnosed with brain tumor; * Capable of cooperating with magnetoencephalography evaluation and recording.

Exclusion criteria

* Patients with serious comorbidities or neurological or psychiatric disorders that affect magnetoencephalography examination. * Patients using drugs that affect central nervous system function; * Patients who are not suitable for surgical procedures; * Patients with progressive neurological disorders.

Design outcomes

Primary

MeasureTime frameDescription
Consistency in Tumor Localization Between Magnetoencephalography (MEG) and Computed Tomography/Magnetic Resonance Imaging (CT/MRI) (Kappa Coefficient)From enrollment to 12 months after surgery.The primary outcome will measure the agreement between MEG and CT/MRI (gold standard) in localizing pediatric brain tumors. Consistency will be quantified using the Kappa coefficient (κ), with sensitivity and specificity calculated for MEG against CT/MRI. Data will be aggregated by comparing preoperative MEG localization results (e.g., tumor location categorized by brain regions) with CT/MRI findings. Statistical analysis will include calculation of κ values (95% confidence interval), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) using SPSS version 27.0.

Countries

China

Contacts

Primary ContactYe Song, Medical Doctor
15625984282@163.com+86-020-81886332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026