NCT04725162

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

7 years

First QC Date

January 25, 2021

Last Update Submit

July 6, 2021

Conditions

Keywords

EpilepsyPeidatricsPositron emission tomography (PET)

Outcome Measures

Primary Outcomes (2)

  • Accuracy

    The accuracy of epilepsy focus localization.

    Through study completion, about 6 months

  • Kappa

    The agreement between experiment result and clinical diagnosis.

    Through study completion, about 6 months

Study Arms (3)

Epilepsy patients

Pediatric patients with focal epilepsy.

Radiation: 18F-FDG

Control

Age-matched controls who underwent 18F-FDG PET/CT examination for diseases outside brains.

Radiation: 18F-FDG

Validation

Children who underwent 18F-FDG PET/MRI to examine extracranial tumors.

Radiation: 18F-FDG

Interventions

18F-FDGRADIATION

All subjects received 18F-FDG PET examination.

ControlEpilepsy patientsValidation

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

  • Zhang T, Li Y, Zhao S, Xu Y, Zhang X, Wu S, Dou X, Yu C, Feng J, Ding Y, Zhu J, Chen Z, Zhang H, Tian M. High-resolution pediatric age-specific 18F-FDG PET template: a pilot study in epileptogenic focus localization. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1560-1573. doi: 10.1007/s00259-021-05611-w. Epub 2021 Nov 8.

MeSH Terms

Conditions

Epilepsy

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 26, 2021

Study Start

July 1, 2014

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Locations