The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06057233
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : December 5, 2023
Sponsor:
Collaborators:
Université Grenoble-Alpes
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Epilepsy, Temporal Lobe Diagnostic Test: mqMRI and GABA-MRS

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : November 2028
Estimated Study Completion Date : November 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients
mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy
 Diagnostic Test: mqMRI and GABA-MRS
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
 Diagnostic Test: mqMRI and GABA-MRS
multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Brain resected tissue

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057233


Contacts
Layout table for location 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

Sponsors and Collaborators
University Hospital, Grenoble
Université Grenoble-Alpes
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Philippe Kahane, MD, PhD Université Grenoble-Alpes
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT06057233    
Other Study ID Numbers: 38RC22.0265_EPI-CATCHER
ANR-21-CE17-0031 ( Other Grant/Funding Number: ANR )
2022-A01949-34 ( Other Identifier: IDRCB )
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: December 5, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
MRI
Quantitative
GABA
MRS
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy, Temporal Lobe
Epilepsy
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes