Clinical trial NCT06057233: Innovative MRI to Localize the Epileptic Zone
Official title: Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy, Temporal Lobe
Keywords: MRI
Quantitative
GABA
MRS
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1 : patients with MTLE epilepsy, candidate to resection surgery Group 2 : healthy volunteers, to obtain reference mqMRI and GABA-MRS values

Brief summary: The goal of EPI-CATCHER is to outline the clinical potential of multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS), combined with machine learning tools, as imaging biomarkers to localize and delineate the EZ.

Detailed description: After informed consent, patient candidate to resection surgery will undergo two extra MRI sessions before surgery: one for multiparametric quantitative MRI (mqMRI) and one for GABA-edited magnetic resonance spectroscopy (GABA-MRS) In parallel, a group of healthy volunteers will also undergo the two MRI sessions described above, to collect reference data.

Eligibility criteria: Inclusion Criteria:

* Patient group

  * Patients aged 18-65 years,
  * Patients with drug-resistant focal epilepsy,
  * Patients with MTLE suspicion, with normal MRI or hippocampal sclerosis, and candidate for surgery,
  * Negative pregnancy test for child-bearing aged woman,
  * Obtained signed informed consent from patient
* Reference group

  * Male or female, 18-65 years,
  * Obtained signed informed consent from participants,
  * Negative pregnancy test for child-bearing aged woman

Exclusion Criteria:

* Patient group

  * Patient without social security system
  * Inability or unwillingness of the individual to provide written informed consent, according to national regulations.
  * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
  * Contraindication for MRI,
  * Contraindication for injection of MRI contrast agent (Gd-Chelate),
  * Evidence on neuroimaging (CT or MRI) of a brain lesion in the same hemisphere as the EZ (tumor, stroke, cerebral edema with midline shift and a clinically significant compression of ventricles, or subarachnoid hemorrhage, or intracerebral parenchymal hematoma (petechial small hemorrhages are NOT a non-inclusion criteria),
  * Severe leucoariosis
  * Pre-existing dementia
  * Pregnant, breastfeeding women
* Reference group

  * Person who is participating in another therapeutic trial
  * Person with a psychiatric disorder, an epilepsy, or a brain lesion susceptible to impact the MRI readouts
  * Person without social security system,
  * Inability or unwillingness of the individual to provide written informed consent, according to national regulations,
  * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
  * Contraindication for MRI
  * Contraindication for injection of MRI contrast agent (Gd-Chelate)
  * Pregnant, breastfeeding woman.

Primary outcomes:
measure: EZmri vs EZsdt
timeFrame: 5 years
Secondary outcomes:
measure: mqMRI : T1 (ms)
timeFrame: 5 years
measure: mqMRI : T2 (ms)
timeFrame: 5 years
measure: mqMRI : Mean Diffusivity (s/mm²)
timeFrame: 5 years
measure: mqMRI : Cerebral Blood Volume (%)
timeFrame: 5 years
measure: mqMRI : Blood-Brain Barrier Permeability (%)
timeFrame: 5 years
measure: GABA
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University Grenoble Alps
name: Philippe Kahane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boux F, Forbes F, Collomb N, Zub E, Maziere L, de Bock F, Blaquiere M, Stupar V, Depaulis A, Marchi N, Barbier EL. Neurovascular multiparametric MRI defines epileptogenic and seizure propagation regions in experimental mesiotemporal lobe epilepsy. Epilepsia. 2021 May;62(5):1244-1255. doi: 10.1111/epi.16886. Epub 2021 Apr 5.
citation: Hamelin S, Stupar V, Maziere L, Guo J, Labriji W, Liu C, Bretagnolle L, Parrot S, Barbier EL, Depaulis A, Fauvelle F. In vivo gamma-aminobutyric acid increase as a biomarker of the epileptogenic zone: An unbiased metabolomics approach. Epilepsia. 2021 Jan;62(1):163-175. doi: 10.1111/epi.16768. Epub 2020 Dec 1.