Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-08 @ 4:27 AM
Study NCT ID:
NCT06828705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establish the First International Database on Semi-quantitative Values Obtained in Scintigraphy With Datscan® in Cadmium-Zinc-Telluride Camera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To create the first international database of Datscan by camera VERITON-CT.', 'timeFrame': 'One day', 'description': 'Fixation ratio of central gray nuclei of the brain namely, the global striatum, caudate nuclei, putamens'}], 'secondaryOutcomes': [{'measure': 'Compare this database with another database from another type of camera (Lyon nuclear medicine team) to show its superiority.', 'timeFrame': 'One day', 'description': 'Identical to the primary evaluation criterion compared to those of the Lyon database.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodegenerative Diseases']}, 'descriptionModule': {'briefSummary': "Datscan scintigraphy is a nuclear medicine examination allowing the diagnosis of neurodegenerative pathologies linked to damage to dopaminergic pathways, such as Parkinson's disease (essential for the differential diagnosis of essential tremor).", 'detailedDescription': "Datscan scintigraphy is a nuclear medicine examination allowing the diagnosis of neurodegenerative pathologies linked to damage to dopaminergic pathways, such as Parkinson's disease (essential for the differential diagnosis of essential tremor).\n\nThere are several types of cameras allowing its performance:\n\n* Conventional Anger cameras and,\n* CZT (Cadmium-Zinc-Telluride) semiconductor cameras. At the Nancy University Hospital, the nuclear medicine department has a wide-field Cadmium-Zinc-Telluride camera: VERITON-CT (Spectrum Dynamics). The interpretation of this examination is purely visual.\n\nThe objectives are therefore to:\n\n* Create the first international database of semi-quantitative values in 3D scintigraphy with Datscan performed with a VERITON-CT camera.\n* Compare this database with another database from a conventional Anger camera (Lyon Nuclear Medicine Department) to show its superiority."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Adult patients who have undergone a Datscan® scintigraphy on the VERITON-CT camera in the nuclear medicine department of the Nancy University Hospital and who have an established clinical diagnosis, in the absence of neurodegenerative pathology or Parkinson's disease or Lewy body disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients who have undergone a Datscan scintigraphy on the VERITON camera in the nuclear medicine department of the Nancy University Hospital and who have an established clinical diagnosis, -Absence of neurodegenerative pathology or Parkinson's disease or Lewy body disease.\n* The clinical diagnosis can only be established after two years of clinical follow-up.\n\nExclusion Criteria:\n\n* Excluded from this research will be the patients opposed to the use of their data, minors, atypical Parkinsonian syndromes,\n* patients who died before two years of clinical follow-up,\n* patients who had their Datscan examination carried out on a camera other than the VERITON and - patients lost to follow-up."}, 'identificationModule': {'nctId': 'NCT06828705', 'acronym': 'DaTBase', 'briefTitle': 'Establish the First International Database on Semi-quantitative Values Obtained in Scintigraphy With Datscan® in Cadmium-Zinc-Telluride Camera', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Establish the First International Database on Semi-quantitative Values Obtained in Scintigraphy With Datscan® in Cadmium-Zinc-Telluride (CZT) Camera (VERITON-CT)', 'orgStudyIdInfo': {'id': '2024PI206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'datscan scintigraphy', 'type': 'OTHER', 'description': 'Semi-quantitative analysis on Datscan imaging scintigraphy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Antoine VERGER, MD,PhD', 'role': 'CONTACT', 'email': 'a.verger@chru-nancy.fr', 'phone': '0383153911', 'phoneExt': '+33'}, {'name': 'Veronique ROCH, MsC', 'role': 'CONTACT', 'email': 'v.roch@chru-nancy.fr', 'phone': '0383154276', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Antoine VERGER', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}