Innovative MRI to Localize the Epileptic Zone

Epilepsy, Temporal Lobe Clinical Trial

— EPI-CATCHER  

Official title:

Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06057233
• Other study ID #: 38RC22.0265_EPI-CATCHER
• Secondary ID: ANR-21-CE17-0031
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: November 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Grenoble
• Contact: Lucie Miquel, MSc
• Phone: +33 4 76 76 63 08
• Email: lmiquel[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy, Temporal Lobe

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Institut National de la Santé Et de la Recherche Médicale, France, Université Grenoble-Alpes

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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