Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-06 @ 7:42 PM
Study NCT ID:
NCT00741559
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2008-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015225', 'term': 'Magnetoencephalography'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D060306', 'term': 'Magnetometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2008-08-25', 'studyFirstSubmitQcDate': '2008-08-25', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The concordance rate of FDG-PET and MEG with video EEG', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epilepsy', 'pediatrics', 'magnetoencephalography', 'electroencephalography', 'positron emission tomography'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The first aim of this study are to evaluate the lobar concordance of FDG-PET and MEG with intracranial electrographic study in children with intractable partial epilepsy. The second aim is to determine if the combined role of FDG-PET and MEG improve detection of epileptogenic zone as defined by invasive intracranial recordings.', 'detailedDescription': 'Children with poorly controlled epilepsy are extensively investigated with various tools including MR brain, electroencephalography (EEG), magnetoencephalography (MEG) or position emission tomography (PET) scans. When MR brain does not show an abnormality, the patient is said to have nonlesional epilepsy. In these cases, it is even more crucial to be able to identify the epileptogenic zone, depending on availability of investigative tool.\n\nRecognizing that individual modalities have limitations, the aim of this study is to determine if combining non-invasive investigations with MEG and PET, which respectively evaluate the electrical and metabolic activity of the brain, could improve the children with intractable nonlesional epilepsy with MEG and PET and compared this with invasive intracranial monitoring. The endpoint of the study being agreement on localizations of epileptogenic zone using PET and MEG individually and in combination and comparing this with invasive intracranial monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between the ages 0-18 years with (1) nonlesional intractable focal epilepsy and (2) those with discordant clinical and EEG findings, who are potential surgical candidates\n\nExclusion Criteria:\n\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT00741559', 'briefTitle': 'Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Combined Role of PET and MEG in Nonlesional Epilepsy in Pediatric Population', 'orgStudyIdInfo': {'id': '1000011429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: magnetoencephalography', 'Device: Positron emission tomography (PET)', 'Device: Magnetic resonance imaging']}], 'interventions': [{'name': 'magnetoencephalography', 'type': 'DEVICE', 'description': 'MEG studies are performed using a whole-head Omega 151-channel gradiometer system.', 'armGroupLabels': ['1']}, {'name': 'Positron emission tomography (PET)', 'type': 'DEVICE', 'description': 'An interictal FDG(fluoro-D-glucose)-PET will be obtained in a single 10 minute scanning session. PET scans will be obtained using a 3D acquisition technique, which will allow the use of a lower dose of radiotracer.', 'armGroupLabels': ['1']}, {'name': 'Magnetic resonance imaging', 'type': 'DEVICE', 'description': 'MR will be performed on a 1.5T or 3T system, using a combination of different sequences including sagittal T1, coronal and axial T2, FLAIR and proton density and axial 3D T1 weighted images.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Martin Charron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nuclear Medicine Radiologist', 'investigatorFullName': 'Amer Shammas', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}