EpilepsyEPINENCT05455047
Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy
An observational study of Epilepsy, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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% . Read more about this study
- Who is it for?
- Ages 18 to 56 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- PET-CT at 18F-FDG
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 1 Jun 2022
- 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 18 to 56 years
- All sexes
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Epilepsy
- Being tested
- PET-CT at 18F-FDG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT at 18F-FDGDiagnostic test
PET-CT at 18f6FDG in nuclear medicine departement of Nancy's hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic connectivity
Metabolic connectivity of hypometabolic clusters in each temporal epilepsy subgroup defined by IRCA (interregional correlation analysis) and graph theory
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
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.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455047
- Sponsor's protocol ID
- 2021PI190
- Acronym
- EPINE
- Status last verified
- Dec 2021
- First submitted
- 13 Oct 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy
- ClinicalTrials.gov ID
- NCT05455047
- Acronym / sponsor ID
- EPINE / 2021PI190
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Jul 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| PET-CT at 18F-FDGPET-CT at 18f6FDG in nuclear medicine departement of Nancy's hospital | Diagnostic test | – |
Primary outcome
Metabolic connectivity
Time frame: 1 month
Metabolic connectivity of hypometabolic clusters in each temporal epilepsy subgroup defined by IRCA (interregional correlation analysis) and graph theory
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 24 Aug 2022.
- Individual participant dataSharing planned: No
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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 Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 3 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 24 Aug 2022. 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 France. 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?
Metabolic connectivity (time frame: 1 month). 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 24 Aug 2022.