18F-FDG PET Imaging Analysis of Antiepileptic Drug Respon... | NCT04357236

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

NCT04357236

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Completed

Last Update Posted

Apr 22, 2020Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Benign Epilepsy With Centrotemporal Spikes

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Mar 30, 2020Actual

Completion Date

Apr 20, 2020Actual

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

Apr 20, 2020

First Posted Date

Apr 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2020

Last Update Posted Date

Apr 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group		The experimental group received 18F-FDG PET examination
Control Group		The control group received 18F-FDG PET examination

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients with benign epilepsy with centrotemporal spikes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019305	Epilepsy, Rolandic

Ancestor Terms

ID	Term
D004828	Epilepsies, Partial
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided