Epileptogenic Focus Localization for Children With Epilepsy Using 18F-FDG PET Molecular Imaging

Completed

• Conditions: Epilepsy
• Interventions: Radiation: 18F-FDG

• Registration Number: NCT04725162
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with epilepsy.

Detailed Description

This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with intractable epilepsy.

Pediatric patients with intractable epilepsy would be retrospectively included in this study. The inclusion criteria included (1) age between 6 and 18 y; (2) detailed seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/CT examination; (3) clinical diagnosis as focal epilepsy. The exclusion criteria included (a) any history of central nervous system disease; (b) poor image quality due to head movement.

Study Timeline

• Study Start: 2014-07-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• 1. age between 6 and 18 years.
• 2. detailed presurgical evaluation, including seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/Computer Tomography (CT) examination.
• 3. clinical diagnosis as focal epilepsy.

Exclusion Criteria

• 1. any history of central nervous system (CNS) disease such as trauma and CNS tumor.
• 2. poor image quality due to head movement.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy patients	18F-FDG	Pediatric patients with focal epilepsy.
Validation	18F-FDG	Children who underwent 18F-FDG PET/MRI to examine extracranial tumors.
Control	18F-FDG	Age-matched controls who underwent 18F-FDG PET/CT examination for diseases outside brains.

Primary Outcome Measures

Name	Time	Method
Accuracy	Through study completion, about 6 months	The accuracy of epilepsy focus localization.
Kappa	Through study completion, about 6 months	The agreement between experiment result and clinical diagnosis.

Trial Locations

Locations (1)

Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China