Innovative MRI to Localize the Epileptic Zone

Not yet recruiting

• Conditions: Epilepsy, Temporal Lobe
• Interventions: Diagnostic Test: mqMRI and GABA-MRS

• Registration Number: NCT06057233
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Study Start: 2024-10
• Primary Completion: 2028-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	mqMRI and GABA-MRS	mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy
Volunteers	mqMRI and GABA-MRS	mqMRI and GABA-MRS data will be collected in healthy volunteers

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 : 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
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 : 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 : 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
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