Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT04007627
Status:
UNKNOWN
Last Update Posted:
2019-07-05
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assesment of image quality by radiologists blinded to the simulated dose level', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Three different radiologists will score the images of localizations of abdomen, thorax, pelvis, spine independently by using a dedicated image quality scoring grid.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALADA', 'IQ', 'Pediatric Radiology'], 'conditions': ['Pediatric Radiology']}, 'descriptionModule': {'briefSummary': 'To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).', 'detailedDescription': 'The study will investigate the minimum dose required to obtain acceptable image quality for different pediatric localizations (abdomen, thorax, pelvis, spine) by using a simulation tool of different dose levels. Three different radiologists blinded to the simulated dose level will score the images independently by using a dedicated image quality scoring grid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged under 18 years and under 80 kg;\n* Prior radiography perfomed within 6 months before the beginning of the study.\n\nExclusion Criteria:\n\n\\- Refusal of parents to participate to the study.'}, 'identificationModule': {'nctId': 'NCT04007627', 'acronym': 'DRAPOPED', 'briefTitle': 'Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography', 'orgStudyIdInfo': {'id': '19CAM-DRAPOPED'}}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Catherine Adamsbaum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculté de Médecine Paris Sud, Service de Radiologie Pédiatrique, C.H.U. Bicêtre'}, {'name': 'Joëlle Feghali, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Service de Radiologie Pédiatrique, C.H.U. Bicêtre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}