Innovative MRI to Localize the Epileptic Zone (EPI-CATCHER)

• ClinicalTrials.gov Identifier: NCT06057233
• Recruitment Status: Not yet recruiting
• First Posted: September 28, 2023
• Last Update Posted: December 5, 2023
• Sponsor: University Hospital, Grenoble
• Collaborators: Université Grenoble-Alpes; Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): University Hospital, Grenoble

Tracking Information

• First Submitted Date: September 19, 2023
• First Posted Date: September 28, 2023
• Last Update Posted Date: December 5, 2023
• Estimated Study Start Date: March 2024
• Estimated Primary Completion Date: November 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2023)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 2, 2023)

• 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
• 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
• 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
• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: September 19, 2023)

• mqMRI [ 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
• GABA [ Time Frame: 5 years ]
  Compare, for each patient, the amplitude of GABA and other metabolites available using proton MRS in the EZsdt with the mean values obtained in the same region across the healthy volunteers

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Innovative MRI to Localize the Epileptic Zone
• Official Title: Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone
• 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.
• 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Brain resected tissue

• 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
• Condition: Epilepsy, Temporal Lobe

Intervention

Diagnostic Test: mqMRI and GABA-MRS

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

Study Groups/Cohorts

• Patients
  mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy
  Intervention: Diagnostic Test: mqMRI and GABA-MRS
• Volunteers
  mqMRI and GABA-MRS data will be collected in healthy volunteers
  Intervention: Diagnostic Test: mqMRI and GABA-MRS

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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 19, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2028
• Estimated Primary Completion Date: November 2028 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Lucie Miquel, MSc; +33 4 76 76 63 08; lmiquel@chu-grenoble.fr

Contact: Emmanuel L Barbier, PhD; emmanuel.barbier@univ-grenoble-alpes.fr

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06057233
• Other Study ID Numbers: 38RC22.0265_EPI-CATCHER; ANR-21-CE17-0031 ( Other Grant/Funding Number: ANR ); 2022-A01949-34 ( Other Identifier: IDRCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Hospital, Grenoble
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Grenoble
• Original Study Sponsor: Same as current

Collaborators

• Université Grenoble-Alpes
• Institut National de la Santé Et de la Recherche Médicale, France

Investigators

• Principal Investigator: Philippe Kahane, MD, PhD; Université Grenoble-Alpes

• PRS Account: University Hospital, Grenoble
• Verification Date: December 2023