NCT04169581

Brief Summary

This study aims to use radiomics analysis and deep learning approaches for seizure focus detection in pediatric patients with temporal lobe epilepsy (TLE). Ten positron emission tomograph (PET) radiomics features related to pediatric temporal bole epilepsy are extracted and modelled, and the Siamese network is trained to automatically locate epileptogenic zones for assistance of diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 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

June 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
Last Updated

January 2, 2020

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

November 13, 2019

Last Update Submit

December 30, 2019

Conditions

Keywords

Deep LearningTemporal Lobe EpilepsyPositron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • The 'area under curve' (AUC ) of our model in detection performance

    To evaluate the performance of our model, the investigators calculated the AUC of our model for normal or abnormal classification campared with different methods and and physicians with different levels.

    Through study completion, about 1 year

Secondary Outcomes (1)

  • The 'dice similarity coefficient' (DSC) of our model in detection performance

    Through study completion, about 3 months

Study Arms (2)

Experimental Group

The experimental group received 18F-FDG PET examination

Control Group

The control group received 18F-FDG PET examination

Eligibility Criteria

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

Pediatric patients with Temporal Lobe Epilepsy

You may qualify if:

  • Clinical diagnosis of temporal lobe epilepsy.
  • Age range from six to eighteen years old.
  • Underwent PET, EEG, computed tomography (CT) and MRI.

You may not qualify if:

  • Image quality is unsatisfactory (e.g. severe image artifacts due to head movement).
  • F-FDG PEG examination is negative.
  • Clinical data is incomplete.
  • EEG or MRI report is missing.

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 Q, Liao Y, Wang X, Zhang T, Feng J, Deng J, Shi K, Chen L, Feng L, Ma M, Xue L, Hou H, Dou X, Yu C, Ren L, Ding Y, Chen Y, Wu S, Chen Z, Zhang H, Zhuo C, Tian M. A deep learning framework for 18F-FDG PET imaging diagnosis in pediatric patients with temporal lobe epilepsy. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2476-2485. doi: 10.1007/s00259-020-05108-y. Epub 2021 Jan 9.

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Design

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

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 20, 2019

Study Start

June 1, 2018

Primary Completion

February 28, 2019

Study Completion

April 30, 2019

Last Updated

January 2, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations