Innovative MRI to Localize the Epileptic Zone

NCT ID: NCT06057233

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2028-11-30

Brief Summary

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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

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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.

Conditions

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Epilepsy, Temporal Lobe

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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

mqMRI and GABA-MRS

Intervention Type DIAGNOSTIC_TEST

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

mqMRI and GABA-MRS

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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mqMRI and GABA-MRS

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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.

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),
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Grenoble Alps

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Kahane, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Grenoble Alps

Central Contacts

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Lucie Miquel, MSc

Role: CONTACT

+33 4 76 76 63 08

Emmanuel L Barbier, PhD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 33818790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33258489 (View on PubMed)

Other Identifiers

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ANR-21-CE17-0031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022-A01949-34

Identifier Type: OTHER

Identifier Source: secondary_id

38RC22.0265_EPI-CATCHER

Identifier Type: -

Identifier Source: org_study_id

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