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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725162
• Other study ID #: 2020-862
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Radiation:
• 18F-FDG
All subjects received 18F-FDG PET examination.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	The accuracy of epilepsy focus localization.	Through study completion, about 6 months
Primary	Kappa	The agreement between experiment result and clinical diagnosis.	Through study completion, about 6 months