Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-08 @ 4:56 AM
Study NCT ID:
NCT03311256
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2017-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of the "Tissue Transit Time" (TTT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': '3 to 6 months', 'description': 'Estimation of Sensitivity and Specificity of a delayed tissue transit time as a diagnostic factor concerning worsening of the differential renal function in patients with congenital ureteropelvic junction obstruction'}], 'secondaryOutcomes': [{'measure': 'Examination of ultrasound findings', 'timeFrame': '3 to 6 months', 'description': 'Relationship between ultrasound findings and the development of the differential renal function'}, {'measure': 'Examination of renal drainage', 'timeFrame': '3 to 6 months', 'description': 'Relationship between initial quality of renal drainage and the development of the differential renal function'}, {'measure': 'Examination of initial differential renal function', 'timeFrame': '3 to 6 months', 'description': 'Relationship between initial differential renal function and the development of the differential renal function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue Transit Time'], 'conditions': ['Renal Insufficiency, Acute']}, 'referencesModule': {'references': [{'pmid': '37718234', 'type': 'DERIVED', 'citation': 'Luithle T, Obermayr F, Dittmann H, Engel C, Etzler A, Kosch F, Menke IT, Schafer M, Schuster T, Younsi N, Fuchs J. Determination of tissue tracer transit of Technetium-99m-mercaptoacetyltriglycine diuretic renography in infants with suspected ureteropelvic junction obstruction - A multicenter prospective observational study. J Pediatr Urol. 2023 Dec;19(6):780.e1-780.e7. doi: 10.1016/j.jpurol.2023.08.029. Epub 2023 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Determination of Tissue Transit Time (TTT) as a parameter with high prognostic value to predict the functional course of the differential renal function and the development of the differential renal function after pyeloplasty', 'detailedDescription': 'The ureteropelvic junction obstruction occurs in around 13% of children with antenatally diagnosed hydronephrosis. It remains a controversial topic what prognostic factors may be predictive for deterioration of the differential renal function.\n\nThe tissue transit time (TTT) in the 99mTc- MAG3 diuretic renogram seems to be a predictive factor for the deterioration of the differential renal function in these patients. We therefore analyze the tissue transit time in the 99mTc- MAG3 diuretic renogram in a prospective multicenter observational study to determine it as a prognostic and diagnostic factor. Aim of the study is to differentiate which children could be treated conservatively and which will benefit from operative pyeloplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Term born infants \\<= 3 months of age with a unilateral, insolated hydronephrosis \\>= grade III (SFU)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral, isolated hydronephrosis \\>= grade III (SFU)\n* age \\<= 3 months\n\nExclusion Criteria:\n\n* associated malformation of the urogenital tract\n* global kidney insufficiency proven by creatinine examination\n* prematurity\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT03311256', 'briefTitle': 'Determination of the "Tissue Transit Time" (TTT)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Determination of the "Tissue Transit Time" (TTT) in the MAG3-Tc99 Diuretic Renogram for Risk Stratification of Infants With Ureteropelvic Junction Obstruction - a Multicentric Prospective Observational Study', 'orgStudyIdInfo': {'id': 'TTT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tissue Transit Time', 'type': 'DIAGNOSTIC_TEST', 'description': 'Determination of Tissue Transit Time as a prognostic and diagnostic factor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Kinderchirurgische Klinik', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '28205', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinik für Kinderchirurgie und Kinderurologie', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Klinik für Kinderchirurgie und Kinderurologie', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Kinderchirurgische Klinik', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Zentrum für Kinder- und Jugendurologie', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Klinik für Kinderchirurgie', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': "Cnopf'sche Kinderklinik", 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedzin', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Kinderchiurgische Klinik, Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Tobias Luithle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universtiätsklinikum Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}