Benign Epilepsy With Centrotemporal SpikesNCT04357236
18F-FDG PET Imaging Analysis of Antiepileptic Drug Response in BECTS
An observational study of Benign Epilepsy With Centrotemporal Spikes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Benign Epilepsy With Centrotemporal Spikes
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with benign epilepsy with centrotemporal spikes
Who may be able to join
- 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
Who cannot join
- 1.any history of neurological disorders, such as head trauma, tumor or infarct
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: 18F-FDG PET Imaging Analysis of Antiepileptic Drug Response in Benign Epilepsy With Centrotemporal Spikes Patients
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.
Read the 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.
- Keywords
- Benign Epilepsy with Centrotemporal Spikes, glucose metabolism, positron emission tomography, machine learning
- Medical subject headings
- Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | The experimental group received 18F-FDG PET examination | |
| Control Group | The control group received 18F-FDG PET examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jun 2019
- Primary completion30 Mar 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Epilepsy With Centrotemporal SpikesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357236
- Sponsor's protocol ID
- 2019-437
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FDG PET Imaging Analysis of Antiepileptic Drug Response in Benign Epilepsy With Centrotemporal Spikes Patients
- ClinicalTrials.gov ID
- NCT04357236
- Acronym / sponsor ID
- 2019-437
- Keywords
- Benign Epilepsy with Centrotemporal Spikes, glucose metabolism, positron emission tomography, machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –The experimental group received 18F-FDG PET examination |
| Control Group | – | –The control group received 18F-FDG PET examination |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with benign epilepsy with centrotemporal spikes
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 1.any history of neurological disorders, such as head trauma, tumor or infarct
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The 'area under curve' (AUC ) of our model in classification performance
Time frame: Through study completion, about 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Epilepsy With Centrotemporal Spikes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 'area under curve' (AUC ) of our model in classification performance (time frame: Through study completion, about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.