Epilepsy, Temporal Lobe
Conditions
Keywords
MRI, Quantitative, GABA, MRS
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.
Interventions
DIAGNOSTIC_TESTmqMRI and GABA-MRS
multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)
Sponsors
University Grenoble Alps
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Grenoble
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EZmri vs EZsdt | 5 years | The correlation coefficient between the Dice similarity coefficient (= 2 \* the Area of Overlap between EZMRI and EZsdt divided by the total number of pixels in EZMRI and EZsdt) and the reduction in seizure frequency (= seizure frequency one year after surgery / seizure frequency at inclusion). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mqMRI : T2 (ms) | 5 years | Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers |
| mqMRI : Mean Diffusivity (s/mm²) | 5 years | Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers |
| mqMRI : T1 (ms) | 5 years | Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers |
| mqMRI : Blood-Brain Barrier Permeability (%) | 5 years | Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers |
| GABA | 5 years | Compare, for each patient, the amplitude of GABA and other metabolites available using proton MRS (N-acetyl aspartate and N-acetyl-aspartyl-glutamate (NAA) Creatine and phosphocreatine (Cr), Choline (Cho), Myo-inositol, myo-inositol-monophosphate and glycine (mI), Glutamine (Gln), glutamate (Glu), Lipids (LipX), Lactate (Lac)) in the EZsdt with the mean values obtained in the same region across the healthy volunteers |
| mqMRI : Cerebral Blood Volume (%) | 5 years | Compare, for each patient, the mqMRI parameter values measured in the EZsdt with the mean mqMRI parameter values obtained in the same region across the healthy volunteers |
Contacts
Primary ContactLucie Miquel, MSc
Backup ContactEmmanuel L Barbier, PhD
Outcome results
None listed