Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-07 @ 5:43 AM
Study NCT ID:
NCT05355857
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2022-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Healthy volunteers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers', 'timeFrame': '30 minutes after 18F-FDG injection', 'description': 'Evaluation of tracer activity at the cerebral level on the acquisition images'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FDG PET', 'PET-MRI', 'atlas', 'brain'], 'conditions': ['Brain Diseases']}, 'descriptionModule': {'briefSummary': 'With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.\n\nAccurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).', 'detailedDescription': 'This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 20 to 50\n* Absence of any history or cardiovascular, neurological or psychiatric deficit\n* Signed the informed consent\n\nExclusion Criteria:\n\n* Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG\n* People using a pacemaker or insulin pump\n* People wearing a metal prosthesis or an intracerebral clip\n* People with intraocular metal splinters\n* People with a pathology considered incompatible for the production of the atlas according to the investigator\n* Pregnant women and breastfeeding women\n* Subject in period of exclusion.'}, 'identificationModule': {'nctId': 'NCT05355857', 'acronym': 'ATLATEP', 'briefTitle': 'Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.', 'orgStudyIdInfo': {'id': '2021-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '18F-FDG injection', 'description': 'Health volunteers with 18-F-FDG injection', 'interventionNames': ['Diagnostic Test: brain PET-MRI with 18F-FDG']}], 'interventions': [{'name': 'brain PET-MRI with 18F-FDG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers', 'armGroupLabels': ['18F-FDG injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'country': 'France', 'facility': 'Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'collaborators': [{'name': 'ICube Laboratory', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}