NCT05455047

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

August 24, 2022

Status Verified

December 1, 2021

Enrollment Period

28 days

First QC Date

October 13, 2021

Last Update Submit

August 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Metabolic connectivity

    Metabolic connectivity of hypometabolic clusters in each temporal epilepsy subgroup defined by IRCA (interregional correlation analysis) and graph theory

    1 month

Interventions

PET-CT at 18F-FDGDIAGNOSTIC_TEST

PET-CT at 18f6FDG in nuclear medicine departement of Nancy's hospital

Eligibility Criteria

Age18 Years - 56 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who came to the nuclear medicine department between 2009 and 2021 for an 18F-FDG PET/CT scan as part of a pre-operative assessment for epilepsy surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy's Hospital

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 13, 2021

First Posted

July 13, 2022

Study Start

February 1, 2022

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

August 24, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations