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

Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy, Temporal Lobe
• Intervention / Treatment: Diagnostic test: mqMRI and GABA-MRS

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 Type: Observational
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucie Miquel, MSc; Phone Number: +33 4 76 76 63 08; Email: lmiquel@chu-grenoble.fr
• Study Contact Backup: Name: Emmanuel L Barbier, PhD; Email: emmanuel.barbier@univ-grenoble-alpes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy	Diagnostic test: mqMRI and GABA-MRS; multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)
Volunteers; mqMRI and GABA-MRS data will be collected in healthy volunteers	Diagnostic test: mqMRI and GABA-MRS; multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years
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	5 years
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	5 years
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	5 years
mqMRI : Blood-Brain Barrier Permeability (%)	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	5 years
GABA	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	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Université Grenoble-Alpes
• Investigators: Principal Investigator: Philippe Kahane, MD, PhD, Université Grenoble-Alpes

Publications and helpful links

General Publications

• Boux F, Forbes F, Collomb N, Zub E, Maziere L, de Bock F, Blaquiere M, Stupar V, Depaulis A, Marchi N, Barbier EL. Neurovascular multiparametric MRI defines epileptogenic and seizure propagation regions in experimental mesiotemporal lobe epilepsy. Epilepsia. 2021 May;62(5):1244-1255. doi: 10.1111/epi.16886. Epub 2021 Apr 5.
• Hamelin S, Stupar V, Maziere L, Guo J, Labriji W, Liu C, Bretagnolle L, Parrot S, Barbier EL, Depaulis A, Fauvelle F. In vivo gamma-aminobutyric acid increase as a biomarker of the epileptogenic zone: An unbiased metabolomics approach. Epilepsia. 2021 Jan;62(1):163-175. doi: 10.1111/epi.16768. Epub 2020 Dec 1.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MRI; MRS; GABA; Quantitative
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsy; Epilepsies, Partial; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 38RC22.0265_EPI-CATCHER; ANR-21-CE17-0031 (Other Grant/Funding Number: ANR); 2022-A01949-34 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No