Innovative MRI to Localize the Epileptic Zone

NCT06057233 | Not Yet Recruiting

• 3 other identifiers: 38RC22.0265_EPI-CATCHERANR-21-CE17-00312022-A01949-34
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy, Temporal Lobe

Keywords

MRI; Quantitative; GABA; MRS

Outcome Measures

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).

  5 years

Secondary Outcomes (6)

• mqMRI : T1 (ms)

  5 years

• mqMRI : T2 (ms)

  5 years

• mqMRI : Mean Diffusivity (s/mm²)

  5 years

• mqMRI : Cerebral Blood Volume (%)

  5 years

• mqMRI : Blood-Brain Barrier Permeability (%)

  5 years

Study Arms (2)

Patients

mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy

Diagnostic Test: mqMRI and GABA-MRS

Volunteers

mqMRI and GABA-MRS data will be collected in healthy volunteers

Diagnostic Test: mqMRI and GABA-MRS

Interventions

mqMRI and GABA-MRS DIAGNOSTIC_TEST

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

Patients; Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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),
• 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.),

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Grenoble Alps: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Related Publications (2)

• 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.

  PMID: 33818790 BACKGROUND

• 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.

  PMID: 33258489 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Brain resected tissue

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Philippe Kahane, MD, PhD

  University Grenoble Alps

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucie Miquel, MSc

CONTACT

+33 4 76 76 63 08; lmiquel@chu-grenoble.fr

Emmanuel L Barbier, PhD

CONTACT

emmanuel.barbier@univ-grenoble-alpes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share