EpilepsyNCT04725162
Epileptogenic Focus Localization for Children With Epilepsy Using 18F-FDG PET Molecular Imaging
An observational study of Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with epilepsy. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- 18F-FDG
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2014to 30 Jun 2021
- 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: 130 pediatric patients with focal epilepsy, 67 age-matched controls, and 37 validation group children.
Who may be able to join
- 1. age between 6 and 18 years.
- 2. detailed presurgical evaluation, including seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/Computer Tomography (CT) examination.
- 3. clinical diagnosis as focal epilepsy.
Who cannot join
- 1. any history of central nervous system (CNS) disease such as trauma and CNS tumor.
- 2. poor image quality due to head movement.
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
This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with epilepsy.
Read the detailed description
This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with intractable epilepsy.
Pediatric patients with intractable epilepsy would be retrospectively included in this study. The inclusion criteria included (1) age between 6 and 18 y; (2) detailed seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/CT examination; (3) clinical diagnosis as focal epilepsy. The exclusion criteria included (a) any history of central nervous system disease; (b) poor image quality due to head movement.
- Conditions
- Epilepsy
- Being tested
- 18F-FDG
- Keywords
- Epilepsy, Peidatrics, Positron emission tomography (PET)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGRadiation
All subjects received 18F-FDG PET examination.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patients | Pediatric patients with focal epilepsy. Receives: Radiation: 18F-FDG | |
| Control | Age-matched controls who underwent 18F-FDG PET/CT examination for diseases outside brains. Receives: Radiation: 18F-FDG | |
| Validation | Children who underwent 18F-FDG PET/MRI to examine extracranial tumors. Receives: Radiation: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The accuracy of epilepsy focus localization.
Measured: Through study completion, about 6 months
Kappa
The agreement between experiment result and clinical diagnosis.
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 posted26 Jan 2021
- Study start1 Jul 2014
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725162
- Sponsor's protocol ID
- 2020-862
- Status last verified
- Jul 2021
- First submitted
- 25 Jan 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang T, Li Y, Zhao S, Xu Y, Zhang X, Wu S, Dou X, Yu C, Feng J, Ding Y, Zhu J, Chen Z, Zhang H, Tian M. High-resolution pediatric age-specific 18F-FDG PET template: a pilot study in epileptogenic focus localization. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1560-1573. doi: 10.1007/s00259-021-05611-w. Epub 2021 Nov 8.
PubMed 34746970
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epileptogenic Focus Localization for Children With Epilepsy Using 18F-FDG PET Molecular Imaging
- ClinicalTrials.gov ID
- NCT04725162
- Acronym / sponsor ID
- 2020-862
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Peidatrics, Positron emission tomography (PET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Jan 2021 (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 retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with epilepsy.
Detailed description
This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with intractable epilepsy.
Pediatric patients with intractable epilepsy would be retrospectively included in this study. The inclusion criteria included (1) age between 6 and 18 y; (2) detailed seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/CT examination; (3) clinical diagnosis as focal epilepsy. The exclusion criteria included (a) any history of central nervous system disease; (b) poor image quality due to head movement.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients | – | Radiation: 18F-FDGPediatric patients with focal epilepsy. |
| Control | – | Radiation: 18F-FDGAge-matched controls who underwent 18F-FDG PET/CT examination for diseases outside brains. |
| Validation | – | Radiation: 18F-FDGChildren who underwent 18F-FDG PET/MRI to examine extracranial tumors. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 130 pediatric patients with focal epilepsy, 67 age-matched controls, and 37 validation group children.
Key inclusion criteria (3 listed)
- 1. age between 6 and 18 years.
- 2. detailed presurgical evaluation, including seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/Computer Tomography (CT) examination.
- 3. clinical diagnosis as focal epilepsy.
Key exclusion criteria (2 listed)
- 1. any history of central nervous system (CNS) disease such as trauma and CNS tumor.
- 2. poor image quality due to head movement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDGAll subjects received 18F-FDG PET examination. | Radiation | Control, Epilepsy patients, Validation |
Primary outcome
Accuracy
Time frame: Through study completion, about 6 months
The accuracy of epilepsy focus localization.
Kappa
Time frame: Through study completion, about 6 months
The agreement between experiment result and clinical diagnosis.
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 12 Jul 2021.
- Derived from this study: PubMed 34746970Zhang T, Li Y, Zhao S, Xu Y, Zhang X, Wu S, Dou X, Yu C, Feng J, Ding Y, Zhu J, Chen Z, Zhang H, Tian M. High-resolution pediatric age-specific 18F-FDG PET template: a pilot study in epileptogenic focus localization. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1560-1573. doi: 10.1007/s00259-021-05611-w. Epub 2021 Nov 8.
- Individual participant dataSharing planned: Undecided
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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 Epilepsy, 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 3 inclusion and 2 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 12 Jul 2021. 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?
Accuracy (time frame: Through study completion, about 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725162, which also lists 1 linked publication.
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 12 Jul 2021.