Non-Helium Magnetoencephalography in Pediatric Brain Tumors

NCT06943742 | Recruiting DMC

• 1 other identifier: 449A01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Brain Tumor

Keywords

Magnetoencephalography; Pediatric Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Consistency in Tumor Localization Between Magnetoencephalography (MEG) and Computed Tomography/Magnetic Resonance Imaging (CT/MRI) (Kappa Coefficient)

  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.

  From enrollment to 12 months after surgery.

Interventions

Magnetoencephalography plus Computed Tomography/Magnetic Resonance Imaging DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients of Guangzhou Women and Children's Medical Center

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead
• Beijing X-Magtech Technology Limited: collaborator

Study Sites (1)

Guangzhou Women and Children's medical center

Guangzhou, Guangdong, 511399, China

RECRUITING

MeSH Terms

Interventions

Magnetoencephalography; Tomography, X-Ray Computed; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

Ye Song, Medical Doctor

CONTACT

+86-020-81886332; 15625984282@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 24, 2025
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)