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Innovative MRI to Localize the Epileptic Zone

ConditionEpilepsy, Temporal Lobe
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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.),

Trial population

Group 1 : patients with MTLE epilepsy, candidate to resection surgery Group 2 : healthy volunteers, to obtain reference mqMRI and GABA-MRS values

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • mqMRI and GABA-MRS

    Diagnostic test

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patients1 intervention
Group B: Volunteers1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

mqMRI : T1 (ms)

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

Time frame
5 years
2

mqMRI : T2 (ms)

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

Time frame
5 years
3

mqMRI : Mean Diffusivity (s/mm²)

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

Time frame
5 years
4

mqMRI : Cerebral Blood Volume (%)

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

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Grenoble

Lead sponsor

University Grenoble Alps

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: