Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT04113603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-14
First Post:
2019-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 352}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'diagnostic values of other urinary tract diseases', 'timeFrame': '3 years', 'description': 'sensitivity, specificity and accuracy'}], 'primaryOutcomes': [{'measure': 'diagnostic values of urothelial carcinoma', 'timeFrame': '3 years', 'description': 'sensitivity, specificity, accuracy, area under ROC'}], 'secondaryOutcomes': [{'measure': 'radiation dose', 'timeFrame': '3 years', 'description': 'radiation dose of single bolus versus split bolus CTU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'Single-bolus computed tomography urography (CTU)is a recently developed one-stop imaging examination for diagnosis of urinary tract diseases, including urinary malignancies. However, single-bolus CTU uses two post- contrast phases (i.e.: nephrographic and excretory phases) for diagnosis of urinary tract diseases. A further-developed split-bolus CTU uses solitary post-contrast phase containing mixed information of nephrographic and excretory phases for diagnosis of urinary tract disease; however, whether split-bolus CTU has similar high diagnostic values for urinary malignancies remains unaddressed. Thus, the aim of this study is to compare the diagnostic performance between single-bolus and split-bolus CTU for diagnosing urinary malignancies. This study will enroll 352 patients from two hospitals if they fit the including criteria including aged \\> 40 years old, presenting with gross hematuria or having urinary malignancies histories, normal renal function (i.e.: estimated glomerular filtration rate \\> 60 mL/min/1.73 m2, no allergic history to iodinated contrast medium and no pregnancy). All enrolled patients will be randomized to undergo split-bolus and single-bolus CTU in 1: 1 manner. Two radiologists will read CTU images independently using a standardized recording sheet with Likert scales 1-5 representing higher probabilities of presence of urinary malignancies for larger number). The diagnostic values of split-bolus and single-bolus CTU will analyzed using reference standards by final diagnoses of urinary malignancies (i.e.: presence of urinary malignancies based on histological examinations of cytology examinations, biopsies or surgical specimens). The diagnostic performance of split-bolus CTU and single- bolus CTU for urinary malignancies will be compared using areas under receiver operating curve (ROC) to determine whether there is presence of significant difference .', 'detailedDescription': 'This study will enroll 352 patients. The calculation of sample size is according to the following equation:\n\nn2=〖(Z∝+Zβ/2)〗\\^2/〖(δ-\\|ε\\|)〗\\^2 \\[p1(1-p1)/k+p1(1-p2)\\]\n\n∝=0.05, β=0.2, δ=0.05, p1=0.96, p2=0.80 Then, the number of each arm patient should be ≥ 141 patients. However, if 20 % of the enrolled patients by fitting inclusion criteria are excluded by fitting exclusion criteria, the number of each arem should be ≥ 176 patients. Thus, this study plans to enroll 352 patients (for two arms). The enrolled patients are randomized to two groups (using single-bolus CTU versus using split-bolus CTU) using permuted block method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Fitting all of the followings\n\n1. age ≥ 40 years old\n2. presenting with gross hematuria or having a history of urothelial carcinomas\n3. normal renal function (i.e.: estimated glomerular filtration rate ≧ 60 mL/min/1.73 m2)\n4. no allergy history of iodinated contrast medium\n\nExclusion Criteria: Fitting any of the followings\n\n1. pregnant or lactating woman\n2. withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT04113603', 'briefTitle': 'Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Comparison of Diagnostic Performance of Urothelial Carcinomas Between Single-bolus and Split-bolus Computed Tomography Urography', 'orgStudyIdInfo': {'id': '201701984A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A_Single bolus', 'description': 'Single bolus computed tomography urography (CTU)', 'interventionNames': ['Diagnostic Test: Urinary malignancy']}, {'type': 'EXPERIMENTAL', 'label': 'B_Split bolus', 'description': 'Split bolus computed tomography urography (CTU)', 'interventionNames': ['Diagnostic Test: Urinary malignancy']}], 'interventions': [{'name': 'Urinary malignancy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Single bolus three phase CTU', 'armGroupLabels': ['A_Single bolus', 'B_Split bolus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'state': 'Ta', 'country': 'Taiwan', 'facility': 'Li-Jen Wang', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Li-Jen Wang, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Plan to make individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Imaging Department Director', 'investigatorFullName': 'Li-Jen Wang', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}