Innovative MRI to Localize the Epileptic Zone

N/ANot Yet RecruitingNCT06057233

University Hospital, Grenoble40 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Epilepsy, Temporal Lobe

Interventions

mqMRI and GABA-MRSDIAGNOSTIC_TEST

multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

EZmri vs EZsdt

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).

Time frame: 5 years