Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT06974305
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET/MRI/EEG Imaging Study in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image analysis', 'timeFrame': 'Image analysis to be performed after imaging sessions are complete.', 'description': 'There are no interventions in this study and thus no outcome measures. Primary goal of the study will be achieved with image analysis on the PET/MRI/EEG data.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional PET', 'FDG-PET', 'Functional MRI', 'EEG', 'Epilepsy', 'Neuroimaging', 'Multimodal imaging'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography \\[FDG-PET\\], and blood flow, measured by functional magnetic resonance imaging \\[fMRI\\]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography \\[EEG\\]). The study will also compare how the three imaging modalities localize regions of abnormal function in the brain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study populations are healthy people and people with epilepsy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n\nAdditional Inclusion Criteria for Subjects with Epilepsy:\n\n* Diagnosed with epilepsy with abnormal interictal EEG\n\nExclusion Criteria:\n\n* Contraindications to PET, MRI, or EEG imaging\n* History of severe brain disease such as stroke and head trauma\n* History of brain surgery\n* History of type I or II diabetes mellitus\n* Fasting plasma glucose level \\>200 mg/dL\n* Employed under direct supervision of the PI conducting the research\n\nAdditional Exclusion Criteria for Healthy Subjects:\n\n* Current use of drugs that modulate brain function\n* Current or past history of major medical, neurological, or psychiatric conditions'}, 'identificationModule': {'nctId': 'NCT06974305', 'briefTitle': 'PET/MRI/EEG Imaging Study in Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Investigation of Interictal Metabolic and Electrophysiologic Changes in Epilepsy Through Trimodal Neuroimaging', 'orgStudyIdInfo': {'id': '2022P000929'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls', 'description': 'Healthy control subjects with no major medical history', 'interventionNames': ['Radiation: FDG-PET/fMRI/EEG imaging']}, {'label': 'Subjects with Epilepsy', 'description': 'Subjects diagnosed with epilepsy and with abnormal electrical activity recorded on interictal EEG.', 'interventionNames': ['Radiation: FDG-PET/fMRI/EEG imaging']}], 'interventions': [{'name': 'FDG-PET/fMRI/EEG imaging', 'type': 'RADIATION', 'description': 'Subject will undergo simultaneous EEG, fMRI, and FDG-PET imaging. This includes the use of a standard injected radioactive marker used in PET imaging.', 'armGroupLabels': ['Healthy Controls', 'Subjects with Epilepsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ciprian Catana', 'role': 'CONTACT'}], 'facility': 'Athinoula A. Martinos Center', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'centralContacts': [{'name': 'Magdelena S Allen, BA', 'role': 'CONTACT', 'email': 'mallen27@mgh.harvard.edu', 'phone': '617-724-9232'}], 'overallOfficials': [{'name': 'Ciprian Catana, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Ciprian Catana, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}