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Not yet recruiting NCT06057233

Innovative MRI to Localize the Epileptic Zone

— Observational Epilepsy, Temporal Lobe

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mqMRI and GABA-MRS.
Who it may be relevant to
Registry conditions: Epilepsy, Temporal Lobe. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone

Overview

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.

Interventions

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

Primary outcome measures

  • EZmri vs EZsdt [Time frame: 5 years]
Secondary outcome measures (6)
  • mqMRI : T1 (ms) [Time frame: 5 years]
  • mqMRI : T2 (ms) [Time frame: 5 years]
  • mqMRI : Mean Diffusivity (s/mm²) [Time frame: 5 years]
  • mqMRI : Cerebral Blood Volume (%) [Time frame: 5 years]
  • mqMRI : Blood-Brain Barrier Permeability (%) [Time frame: 5 years]
  • GABA [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 33818790
  • 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

Identifiers

NCT: NCT06057233 · 38RC22.0265_EPI-CATCHER · ANR-21-CE17-0031 · 2022-A01949-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗