- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07316972
CEST-baserede biomarkører til afgrænsning af den epileptogene zone (CEST-BEST)
Epilepsy is a common neurological disorder with an incidence of 1%. Although many anti-seizure medications are available, about 30% of patients are resistant to drug treatments. Epilepsy surgery is an effective treatment for some of these patients. It involves removing the brain region responsible for generating seizures, called the epileptogenic zone (EZ).
A pre-surgical evaluation is performed to locate and delineate the region where seizures originate (the seizure onset zone [SOZ]) and to confirm that this zone is unique and accessible for surgery-that is, that the potential benefits outweigh the risks of functional deficits resulting from its removal. The lesion itself is identified and characterized through post-operative histological examination and, in some cases, based on MRI criteria.
During pre-surgical evaluation, in cases where no lesion is visible on MRI or when surface EEG suggests that a large or multiple epileptic networks may be involved, stereo-electroencephalography (SEEG) is the method of choice to delineate the area for resection. However, SEEG has limitations: it is invasive and records from a restricted brain volume.
Despite advances in neuroimaging techniques, the localization of the epileptogenic zone and mapping of functional brain alterations still need improvement beyond what morphological MRI anomalies can reveal.
Because epileptic tissue is characterized by increased neuronal excitability and metabolic abnormalities, techniques that allow precise evaluation of these changes could deepen our understanding of the disease and provide new tools for epilepsy surgery. An alternative MRI approach based on metabolite quantification using chemical exchange saturation transfer (CEST) has been suggested to aid in localizing the epileptogenic zone in preliminary studies. However, limited availability of ultra-high-field MRI, low localization precision of the epileptogenic zone, and lack of systematic validation in patients have delayed its clinical use.
This study aims to explore a cohort of patients with temporal lobe epilepsy who are candidates for surgery using CEST MRI. We will quantify glutamate and glucose concentrations using glu-CEST and gluco-CEST, respectively, and correlate the results with the localization of the epileptogenic zone determined by pre-surgical evaluation, and where applicable, SEEG and post-operative outcomes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Yavchitz
- Telefonnummer: +33148036454
- E-mail: ayavchitz@for.paris
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with drug-resistant temporal lobe epilepsy (mesial or lateral)
- Requiring a pre-surgical evaluation including long-term video EEG
- At least 5 of them will be recruited after surface video EEG indicates the need for further exploration by SEEG
- With or without a radiologically visible lesion
Exclusion Criteria:
- Absolute or relative contraindication to MRI (metallic implants, including intrauterine devices other than the MIRENA® brand, claustrophobia, etc.)
- Expected inability to remain still for 90 minutes in a 7T MRI
- Diabetic individuals
- Individuals under legal protection measures
- Pregnant or breastfeeding women
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Patienter planlagt til en prekirurgisk evaluering for lægemiddelresistent epilepsi.
|
CEST sequence on a 7-Tesla MRI |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Glukosekoncentration målt med CEST i anfaldets startzone (SOZ)
Tidsramme: Dag 0
|
Dag 0
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Glukosekoncentration målt med CEST i den irritative zone (IZ)
Tidsramme: Dag 0
|
Dag 0
|
|
Glukosekoncentration målt med CEST i udbredelseszonen
Tidsramme: Dag 0
|
Dag 0
|
|
Glutamatkoncentration målt ved CEST i epilepsiens udgangszone (SOZ)
Tidsramme: Dag 0
|
Dag 0
|
|
Glutamatkoncentration målt ved CEST i den irritative zone (IZ)
Tidsramme: Dag 0
|
Dag 0
|
|
Glutamatkoncentration målt med CEST i propagationszonen
Tidsramme: Dag 0
|
Dag 0
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MQS_2024_10
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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