- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05455047
Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy (EPINE)
18F-Fluoro-deoxy-glucose (18F-FDG) positron emission tomography (PET) has a high sensitivity for temporal lobe epilepsy (TLE), the most common form of focal epilepsy, with a detection range of 86-90% . Therefore, 18F-FDG PET is a useful tool to identify the epileptogenic zone (ETZ) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . Based on stereotactic electroencephalography (SEEG) findings, a correspondence between electrical data and metabolic changes on PET was found at the group level by identifying four different patterns of TLE . As expected, hypometabolism was not limited to the EZ defined by SEEG, but underlay broader epileptic networks . Because of the different electroclinical presentations of TLE, 18F-FDG PET appears to be a very useful tool in these temporal epilepsies. Indeed, it has been recently demonstrated that a gradient of PET hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18F-FDG PET in defining the EZ .
Therefore, it is interesting to study PET metabolism as a network and not as a combination of regional metabolic measures in epilepsy.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vandœuvre-lès-Nancy, France, 54511
- Nancy's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with drug-resistant temporal epilepsy with an accurate diagnosis on SEEG
- Patients with epilepsy who have had a PET/CT scan with 18F-FDG as part of a pre-operative assessment
- Person having received complete information on the organization of the research and not having objected to the use of these data;
- Patients affiliated to a social security system
Exclusion Criteria:
- Person who has not received full information on the organization of the research and who has opposed the use of this data
- A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice).
- A person of full age who is unable to give consent and who is not subject to a legal protection measure
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic connectivity
Time Frame: 1 month
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Metabolic connectivity of hypometabolic clusters in each temporal epilepsy subgroup defined by IRCA (interregional correlation analysis) and graph theory
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1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PI190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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