NCT07147309

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
41mo left

Started Sep 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Sep 2025Sep 2029

First Submitted

Initial submission to the registry

August 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

August 19, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Standardized Uptake Value

    Measures of specific binding of TSPO/SV2A/FDG

    2 years

  • Standardized Uptake Value

    Measures of specific binding of TSPO/SV2A/FDG measures of specific binding of the tracer

    2 years

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with drug-resistant focal epilepsy.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Zhang Ying Zhang Ying, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 29, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

August 29, 2025

Record last verified: 2025-08