Non-Helium Magnetoencephalography in Pediatric Brain Tumors

April 22, 2025 updated by: Guangzhou Women and Children's Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511399
        • Recruiting
        • Guangzhou Women And Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients of Guangzhou Women and Children's Medical Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 12 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Collaborators

Beijing X-Magtech Technology Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 449A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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