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NCT Number: NCT06057233

Innovative MRI 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.

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Key information

Conditions

Epilepsy, Temporal Lobe Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epileptic Syndromes Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mqMRI and GABA-MRS

Diagnostic Test

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

Primary outcomes

  1. EZmri vs EZsdt

    Time frame: 5 years

    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).

Secondary outcomes

  1. mqMRI : T1 (ms)

    Time frame: 5 years

    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

  2. mqMRI : T2 (ms)

    Time frame: 5 years

    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

  3. mqMRI : Mean Diffusivity (s/mm²)

    Time frame: 5 years

    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

  4. mqMRI : Cerebral Blood Volume (%)

    Time frame: 5 years

    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. mqMRI : Blood-Brain Barrier Permeability (%)

    Time frame: 5 years

    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

  6. GABA

    Time frame: 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel L Barbier, PhD

CONTACT

[email protected]

Lucie Miquel, MSc

CONTACT

[email protected]

+33 4 76 76 63 08

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • University Grenoble Alps

Registry information

Official study title

Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone

Acronym: EPI-CATCHER

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 28, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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