Non-Helium Magnetoencephalography for Clinical Management of Pediatric Brain Tumors : An Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Consistency in Tumor Localization Between Magnetoencephalography (MEG) and Computed Tomography/Magnetic Resonance Imaging (CT/MRI) (Kappa Coefficient)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 3-18 years old;
- •Clinically diagnosed with brain tumor;
- •Capable of cooperating with magnetoencephalography evaluation and recording.
排除标准
- •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.
结局指标
主要结局
Consistency in Tumor Localization Between Magnetoencephalography (MEG) and Computed Tomography/Magnetic Resonance Imaging (CT/MRI) (Kappa Coefficient)
时间窗: 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.
次要结局
未报告次要终点