Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 6:35 PM
Study NCT ID:
NCT06057233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-23
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative MRI to Localize the Epileptic Zone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}], 'ancestors': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Brain resected tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EZmri vs EZsdt', 'timeFrame': '5 years', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'mqMRI : T1 (ms)', 'timeFrame': '5 years', 'description': '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'}, {'measure': 'mqMRI : T2 (ms)', 'timeFrame': '5 years', 'description': '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'}, {'measure': 'mqMRI : Mean Diffusivity (s/mm²)', 'timeFrame': '5 years', 'description': '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'}, {'measure': 'mqMRI : Cerebral Blood Volume (%)', 'timeFrame': '5 years', 'description': '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'}, {'measure': 'mqMRI : Blood-Brain Barrier Permeability (%)', 'timeFrame': '5 years', 'description': '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'}, {'measure': 'GABA', 'timeFrame': '5 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Quantitative', 'GABA', 'MRS'], 'conditions': ['Epilepsy, Temporal Lobe']}, 'referencesModule': {'references': [{'pmid': '33818790', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33258489', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1 : patients with MTLE epilepsy, candidate to resection surgery Group 2 : healthy volunteers, to obtain reference mqMRI and GABA-MRS values', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient group\n\n * Patients aged 18-65 years,\n * Patients with drug-resistant focal epilepsy,\n * Patients with MTLE suspicion, with normal MRI or hippocampal sclerosis, and candidate for surgery,\n * Negative pregnancy test for child-bearing aged woman,\n * Obtained signed informed consent from patient\n* Reference group\n\n * Male or female, 18-65 years,\n * Obtained signed informed consent from participants,\n * Negative pregnancy test for child-bearing aged woman\n\nExclusion Criteria:\n\n* Patient group\n\n * Patient without social security system\n * Inability or unwillingness of the individual to provide written informed consent, according to national regulations.\n * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),\n * Contraindication for MRI,\n * Contraindication for injection of MRI contrast agent (Gd-Chelate),\n * 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),\n * Severe leucoariosis\n * Pre-existing dementia\n * Pregnant, breastfeeding women\n* Reference group\n\n * Person who is participating in another therapeutic trial\n * Person with a psychiatric disorder, an epilepsy, or a brain lesion susceptible to impact the MRI readouts\n * Person without social security system,\n * Inability or unwillingness of the individual to provide written informed consent, according to national regulations,\n * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),\n * Contraindication for MRI\n * Contraindication for injection of MRI contrast agent (Gd-Chelate)\n * Pregnant, breastfeeding woman.'}, 'identificationModule': {'nctId': 'NCT06057233', 'acronym': 'EPI-CATCHER', 'briefTitle': 'Innovative MRI to Localize the Epileptic Zone', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone', 'orgStudyIdInfo': {'id': '38RC22.0265_EPI-CATCHER'}, 'secondaryIdInfos': [{'id': 'ANR-21-CE17-0031', 'type': 'OTHER_GRANT', 'domain': 'ANR'}, {'id': '2022-A01949-34', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'mqMRI and GABA-MRS data will be collected in patients suffering from mesial temporal lobe epilepsy', 'interventionNames': ['Diagnostic Test: mqMRI and GABA-MRS']}, {'label': 'Volunteers', 'description': 'mqMRI and GABA-MRS data will be collected in healthy volunteers', 'interventionNames': ['Diagnostic Test: mqMRI and GABA-MRS']}], 'interventions': [{'name': 'mqMRI and GABA-MRS', 'type': 'DIAGNOSTIC_TEST', 'description': 'multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS)', 'armGroupLabels': ['Patients', 'Volunteers']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lucie Miquel, MSc', 'role': 'CONTACT', 'email': 'lmiquel@chu-grenoble.fr', 'phone': '+33 4 76 76 63 08'}, {'name': 'Emmanuel L Barbier, PhD', 'role': 'CONTACT', 'email': 'emmanuel.barbier@univ-grenoble-alpes.fr'}], 'overallOfficials': [{'name': 'Philippe Kahane, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Grenoble Alps'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Grenoble Alps', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}