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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04169581
Other study ID # 2019-124
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date April 30, 2019

Study information

Verified date June 2019
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Purpose:The key to successful epilepsy control involves locating epileptogenic focus before treatment. 18F-FDG PET has been considered as a powerful neuroimaging technology used by physicians to assess patients for epilepsy. However, imaging quality, viewing angles, and experiences may easily degrade the consistency in epilepsy diagnosis. In this work, the investigators develop a framework that combines radiomics analysis and deep learning techniques to a computer-assisted diagnosis (CAD) method to detect epileptic foci of pediatric patients with temporal lobe epilepsy (TLE) using PET images.

Methods:Ten PET radiomics features related to pediatric temporal bole epilepsy are first extracted and modelled. Then a neural network called Siamese network is trained to quanti-fy the asymmetricity and automatically locate epileptic focus for diagnosis.The performance of the proposed framework was tested and compared with both the state-of-art clinician software tool and human physicians with different levels of experiences to validate the accuracy and consistency.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date April 30, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

1. Clinical diagnosis of temporal lobe epilepsy.

2. Age range from six to eighteen years old.

3. Underwent PET, EEG, computed tomography (CT) and MRI.

Exclusion Criteria:

1. Image quality is unsatisfactory (e.g. severe image artifacts due to head movement).

2. 18F-FDG PEG examination is negative.

3. Clinical data is incomplete.

4. EEG or MRI report is missing.

Study Design


Related Conditions & MeSH terms


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 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 The 'dice similarity coefficient' (DSC) of our model in detection performance The accuracy of focus lesion detection is quantitatively measured through the metric of 'dice similarity coefficient' (DSC) by comparing the spatial overlap between the marked regions between the reference standard and the subject method under test. Through study completion, about 3 months
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