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

July 6, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

234

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University

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

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

130 pediatric patients with focal epilepsy, 67 age-matched controls, and 37 validation group children.

Description

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 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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: Through study completion, about 6 months
The accuracy of epilepsy focus localization.
Through study completion, about 6 months
Kappa
Time Frame: Through study completion, about 6 months
The agreement between experiment result and clinical diagnosis.
Through study completion, about 6 months

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2014

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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