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NCT Number: NCT06943742

Non-Helium Magnetoencephalography in Pediatric Brain Tumors

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.

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Key information

Conditions

Pediatric Brain Tumor

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's medical center

Guangzhou, Guangdong, 511399, China

Location status: Recruiting

Location contact

Wenhao Zhou, Medical Doctor

CONTACT

[email protected]

+86-020-81886332

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ye Song, Medical Doctor

CONTACT

[email protected]

+86-020-81886332

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Collaborators

  • Beijing X-Magtech Technology Limited

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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