18F-FDG PET Imaging Analysis of Antiepileptic Drug Response in BECTS

Benign Epilepsy With Centrotemporal Spikes Clinical Trial

Official title:

18F-FDG PET Imaging Analysis of Antiepileptic Drug Response in Benign Epilepsy With Centrotemporal Spikes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357236
• Other study ID #: 2019-437
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: April 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This original article is a novel investigation on the metabolic characteristics of different patterns of antiepileptic drug (AED) responses in benign epilepsy with centrotemporal spikes (BECTS) patients using 18F-FDG PET imaging. In this study, we demonstrated remitting-relapsing group showed more widespread hypo-metabolism regions than AED responders. Results indicated that metabolic differences had the ability to distinguish the remitting-relapsing patients from AED responders. 18F-FDG PET could be used as a marker to infer the current seizure activity of BECTS. We think that the established hybrid model based on PET and clinical features may be a critical reference for better personalized medication in patients with BECTS.

Description:

Purpose The current drug treatment of benign epilepsy with centrotemporal spikes (BECTS) mainly depends on the clinical experience of physicians. This study aimed to investigate different patterns of antiepileptic drug (AED) responses in patients with BECTS using 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) imaging for better personalized medication.

Methods A total of 55 patients with BECTS (36 AED responders, 19 remitting-relapsing patients) and 23 pseudo-controls who underwent 18F-FDG PET imaging were retrospectively included. The group comparison was performed to investigate metabolic differences among AED responders, remitting-relapsing patients and pseudo-controls. Three different logistic regression models were employed to distinguish remitting-relapsing patients from AED responders based on clinical features, 18F-FDG PET images and a hybrid of both. Ten AED responders who reduced AED dose and one remitting-relapsing patient who relapsed within one month after PET examination were included in the model evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 20, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 1.clinical diagnosis of BECTS; 2. aging between 6 and 18 years ; 3.taking MRI and EEG examination; 4. taking AEDs as prescribed; 5. continuous 12-month clinical follow-up after 18F-FDG PET examination; 6.the last seizure occurring earlier than 24 h before 18F-FDG PET study

Exclusion Criteria:

• 1.any history of neurological disorders, such as head trauma, tumor or infarct

Related Conditions & MeSH terms

• Benign Epilepsy With Centrotemporal Spikes
• Epilepsy
• Epilepsy, Rolandic

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 classification performance	To evaluate the performance of our model, the investigators calculated the AUC of three different logistic regression models based on clinical features, 18F-FDG PET images and a hybrid of both.	Through study completion, about 6 months