Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT05498532
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional MRI Evaluation in Pyeloureteral Junction Syndrome in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI and scintigraphy differential renal function correlation', 'timeFrame': 'from january 2007 to december 2021', 'description': 'Evaluation of differential renal function between MRI and scintigraphy in children between 0 and 1 year old ; Pearson correlation coefficient'}], 'secondaryOutcomes': [{'measure': 'MRI and scintigraphy differential renal function correlation in operated patient', 'timeFrame': 'from january 2007 to december 2021', 'description': 'Evaluation of differential renal function between MRI and scintigraphy in children operated for PUJS; Pearson correlation coefficient'}, {'measure': 'Time difference in patient operated for PUJS depending on MRI realisation ou MRI and scintigraphy realisation', 'timeFrame': 'from january 2007 to december 2021', 'description': 'Comparison between the mean time between MRI and surgery, and mean time between MRI, scintigraphy and surgery'}, {'measure': 'performance of MRI in detecting polar vessel', 'timeFrame': 'from january 2007 to december 2021', 'description': 'Polar vessel : comparison between MRI results and operatory observation, sensitivity et specificity analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PUJS', 'MRI', 'Scintigraphy', 'Polar Vessel'], 'conditions': ['Stricture of Pelviureteric Juncture']}, 'descriptionModule': {'briefSummary': 'Pyelo-ureteral junction syndrome is the most common urological abnormality in children.\n\nFunctional MRI has been evaluated several times, and had shown good correlation with scintigraphy, but tends to over estimate results. Moreover, those studies included a small number of cases. Its sensitivity to detect crossing polar vessel is limited.\n\nWe aimed to evaluate, in patients between 0 and 1 year old, the correlation between MRI and scintigraphy differential renal function.\n\nOur secondary objectives are : evaluation of MRI performances to detect polar vessel ; comparison of surgery times depending of MRI only realisation or MRI and scintigraphy realisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children between 0 and 17 years old followed for pyelo-ureteral junction syndrome in the Children hospital of Nancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children between 0 and 17 years old\n* followed for pyelo-ureteral junction syndrome\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05498532', 'briefTitle': 'Functional MRI Evaluation in Pyeloureteral Junction Syndrome in Children', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Functional MRI Usage for Pyelo-ureteral Junction Syndrome : Results of Nancy Children Hospital Cohort', 'orgStudyIdInfo': {'id': '2022PI108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PUJS patients', 'description': 'Patients between 0 and 17 years old treated or followed for pyelo-ureteral junction syndrome.', 'interventionNames': ['Diagnostic Test: Functional MRI']}], 'interventions': [{'name': 'Functional MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Renal Scintigraphy'], 'description': 'Anatomical MRI : T2 fiesta, SSFE, HASTE ; 3D T2 ; T1 FAT SAT ; LAVA Functional MRI : T1 FAT SAT with gadolinium', 'armGroupLabels': ['PUJS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54 511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Charles Mazeaud', 'role': 'CONTACT', 'email': 'charles.mazeaud@gmail.com', 'phone': '03 83 85 85 85'}], 'overallOfficials': [{'name': 'Charles Mazeaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Praticien hospitalier universitaire', 'investigatorFullName': 'Charles Mazeaud', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}