Innovative MRI to Localize the Epileptic Zone (EPI-CATCHER)

Grenoble Alpes University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

Epilepsy, Temporal Lobe

Treatments

Diagnostic Test: mqMRI and GABA-MRS

Study type

Observational

Funder types

Other

Identifiers

NCT06057233

38RC22.0265_EPI-CATCHER

ANR-21-CE17-0031 (Other Grant/Funding Number)

2022-A01949-34 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.