Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT02858167
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of neurological impairment detected during standard neurological examination', 'timeFrame': 'Day 0'}, {'measure': 'Mini-mental state score', 'timeFrame': 'Day 0'}, {'measure': 'Frontal Assessment Battery score', 'timeFrame': 'Day 0'}, {'measure': 'Mini International Neuropsychiatric Interview (DSM-IV) score', 'timeFrame': 'Day 0'}, {'measure': 'Montgomery-Åsberg depression rating scale', 'timeFrame': 'Day 0'}, {'measure': 'Absence of cerebral abnormalities detected with PET', 'timeFrame': 'Day 0'}, {'measure': 'Absence of cerebral abnormalities detected with X ray spiral CT', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Instrumental Activities of Daily Living evaluation', 'timeFrame': 'Day 0', 'description': 'Evaluation of the normality of cerebral function in study population'}, {'measure': 'Cerebral FDG distribution', 'timeFrame': 'Day 0', 'description': 'Voxel-based analysis with SPM software of PET data'}, {'measure': 'FDG mean activity in cerebral sections', 'timeFrame': 'Day 0', 'description': 'Automatic measurement of FDG mean fixation in cerebral sections with NeurogamTM (Segami) software in PET data'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define a reference population for FDG-PET neurological examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma (tumor in remission, low disabling chronic tumor).', 'detailedDescription': 'This study will also check normality of cerebral functions in this population and analyse the influence of various variation factors, such as age, sex ratio, education level, professional activity and neuropsychological test results on normal data.\n\nThis database could be later used as comparison to patient images defining the gravity and localization of their cerebral functional disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with tumor in remission or low disabling chronic tumor\n* No parenteral chemotherapy for at least 1 month\n* No glucocorticoid treatment\n* No general health modification (asthenia, anorexia, weight reduction)\n\nExclusion Criteria:\n\n* Patient having a known neurodegenerative disorder, a general disease or physical problems that can interfere with cognitive function\n* Patient with cerebral pathology history (epilepsy, vascular event, cerebral vascular malformation, tumor, severe cranial trauma, meningitis or infectious or inflammatory encephalitis, hydrocephalus, mental retardation…)\n* Patient not having at least 4 years of education\n* Patient having an anxiolytic or anti-depressive treatment\n* Patient refusing to participate to the study\n* Patient incapable to give informed consent (guardianship)'}, 'identificationModule': {'nctId': 'NCT02858167', 'acronym': 'BDD TEP FDG', 'briefTitle': 'Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations: Study of Principal Inter-individual Variation Factors', 'orgStudyIdInfo': {'id': '2008-A00763-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FDG-PET', 'interventionNames': ['Device: FDG-PET']}], 'interventions': [{'name': 'FDG-PET', 'type': 'DEVICE', 'description': 'FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes', 'armGroupLabels': ['FDG-PET']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'country': 'France', 'facility': 'Service de Médecine Nucléaire, Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Marie-Hélène Laurens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Médecine Nucléaire, Hôpital Central, Nancy, France'}, {'name': 'Pierre-Yves MARIE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Médecine Nucléaire, Hôpital Central, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}