Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-27 @ 4:51 AM
Study NCT ID:
NCT06371703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-03
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv).', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Exposure']}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthcare professionals working in nuclear medicine departments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1)Nuclear medicine radiographers with experience in manual prepa-ration of radiopharmaceuticals.\n\n 2\\) Nuclear medicine healthcare professionals with experience in radiopharmaceutical administration.\n\n 3\\) Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\) Nuclear medicine radiographers without experience in manual preparation of radiopharmaceuticals.\n\n 2\\) Nuclear medicine healthcare professionals without experience in radiopharmaceutical administration.\n\n 3\\) Inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT06371703', 'briefTitle': 'Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automated Radiopharmaceutical Preparation and Administration System', 'orgStudyIdInfo': {'id': 'PETCT_INTEGO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'automated system in reducing radiation exposure', 'type': 'RADIATION', 'description': 'evaluate the effectiveness of the automated system in reducing radiation exposure for radiographers involved in PET/CT procedures.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Irccs San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Giuseppe Bonfitto', 'role': 'CONTACT', 'email': 'bonfitto.giuseppe@hsr.it', 'phone': '02-26438384'}, {'name': 'Serena Pichierri', 'role': 'CONTACT', 'email': 'pichierri.serena@hsr.it', 'phone': '02-26438384'}], 'overallOfficials': [{'name': 'Arturo Chiti', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Chiti Arturo', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}