EpilepsyNCT07147309
Multimodal PET Imaging With 18F-FDG/SV2A/TSPO for Resection Planning in Drug-Resistant Epilepsy
An observational study of Epilepsy and PET / MR, run by Weibing Miao, PhD at 1 site in China.
Trial summary
This study focuses on the application value of 18F-FDG, SV2A, and TSPO PET imaging in the preoperative localization of epileptogenic foci in epilepsy. 18F-FDG PET detects glucose metabolism in brain tissue and is characterized by reduced metabolism during the interictal period. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, PET / MR, Synaptic Vesicle Proteins
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with drug-resistant focal epilepsy.
Who may be able to join
- with drug-resistant focal epilepsy defined by ILAE criteria
- Already performed 3.0 T epilepsy-protocol MRI and video-EEG
- Planned resective surgery or stereotactic EEG (SEEG) electrode implantation, and willingness to undergo all three PET scans: ¹⁸F-FDG, SV2A, and TSPO.
- Ability to understand study procedures and provide written informed consent.
- Availability of complete postoperative follow-up data with at least 12-month Engel outcome classification.
Who cannot join
- -History of head trauma ,claustrophobia, rheumatic or autoimmune diseases, psychiatric disorders, severe somatic diseases (neurological,cardiovascular, etc.),previous heart or brain surgery, substance abuse, inability to refrain from hypnotics, magnetic implants, pregnancy, lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Ying Zhang, MD, +86 059187981619, zy201@126.com
张, zy201@126.com
About this study
This study focuses on the application value of 18F-FDG, SV2A, and TSPO PET imaging in the preoperative localization of epileptogenic foci in epilepsy. 18F-FDG PET detects glucose metabolism in brain tissue and is characterized by reduced metabolism during the interictal period. It is currently the most commonly used localization method in clinical practice, especially suitable for temporal lobe epilepsy, but has limited sensitivity to foci with insignificant metabolic changes. SV2A PET targets synaptic vesicle proteins and reflects synaptic density, showing reduced uptake in epileptogenic foci areas. It has high localization accuracy, can effectively supplement the diagnosis of 18F-FDG PET-negative cases, and also has good application prospects in non-temporal lobe epilepsy. TSPO PET monitors microglial activation to reflect neuroinflammation, with increased uptake in epileptogenic foci areas, and has unique auxiliary diagnostic value in refractory epilepsy and cases with concurrent brain injury. The combined application of the three can provide a more comprehensive imaging basis for preoperative localization of epilepsy, helping to optimize surgical plans.
- Conditions
- Epilepsy, PET / MR, Synaptic Vesicle Proteins, Microglial Activation, FDG PET
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value
Measures of specific binding of TSPO/SV2A/FDG measures of specific binding of the tracer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Weibing Miao, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147309
- Sponsor's protocol ID
- FirstAHFujian-2504
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal PET Imaging With 18F-FDG/SV2A/TSPO for Resection Planning in Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07147309
- Acronym / sponsor ID
- FirstAHFujian-2504
- Conditions
- Epilepsy, PET / MR, Synaptic Vesicle Proteins, Microglial Activation, FDG PET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Weibing Miao, PhDUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Aug 2025 (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 study focuses on the application value of 18F-FDG, SV2A, and TSPO PET imaging in the preoperative localization of epileptogenic foci in epilepsy. 18F-FDG PET detects glucose metabolism in brain tissue and is characterized by reduced metabolism during the interictal period. It is currently the most commonly used localization method in clinical practice, especially suitable for temporal lobe epilepsy, but has limited sensitivity to foci with insignificant metabolic changes. SV2A PET targets synaptic vesicle proteins and reflects synaptic density, showing reduced uptake in epileptogenic foci areas. It has high localization accuracy, can effectively supplement the diagnosis of 18F-FDG PET-negative cases, and also has good application prospects in non-temporal lobe epilepsy. TSPO PET monitors microglial activation to reflect neuroinflammation, with increased uptake in epileptogenic foci areas, and has unique auxiliary diagnostic value in refractory epilepsy and cases with concurrent brain injury. The combined application of the three can provide a more comprehensive imaging basis for preoperative localization of epilepsy, helping to optimize surgical plans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with drug-resistant focal epilepsy.
Key inclusion criteria (5 listed)
- with drug-resistant focal epilepsy defined by ILAE criteria
- Already performed 3.0 T epilepsy-protocol MRI and video-EEG
- Planned resective surgery or stereotactic EEG (SEEG) electrode implantation, and willingness to undergo all three PET scans: ¹⁸F-FDG, SV2A, and TSPO.
- Ability to understand study procedures and provide written informed consent.
- Availability of complete postoperative follow-up data with at least 12-month Engel outcome classification.
Key exclusion criteria (1 listed)
- -History of head trauma ,claustrophobia, rheumatic or autoimmune diseases, psychiatric disorders, severe somatic diseases (neurological,cardiovascular, etc.),previous heart or brain surgery, substance abuse, inability to refrain from hypnotics, magnetic implants, pregnancy, lactation
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
Standardized Uptake Value
Time frame: 2 years
Measures of specific binding of TSPO/SV2A/FDG measures of specific binding of the tracer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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.
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 and PET / MR, run by Weibing Miao, PhD 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 5 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Ying Zhang Ying, MD (+86-15005018972, zy201@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Value (time frame: 2 years). 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 21 Jul 2026.