Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography
Comparison of Diagnostic Performance of Urothelial Carcinomas Between Single-bolus and Split-bolus Computed Tomography Urography
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 .
This study will enroll 352 patients. The calculation of sample size is according to the following equation: n2=〖(Z∝+Zβ/2)〗^2/〖(δ-|ε|)〗^2 [p1(1-p1)/k+p1(1-p2)] ∝=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.
diagnostic values of urothelial carcinoma
Study Arms / Comparison Groups
Description: Single bolus computed tomography urography (CTU)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
June 1, 2019
July 31, 2021
Primary Completion Date
July 31, 2021
Inclusion Criteria: Fitting all of the followings 1. age ≥ 40 years old 2. presenting with gross hematuria or having a history of urothelial carcinomas 3. normal renal function (i.e.: estimated glomerular filtration rate ≧ 60 mL/min/1.73 m2) 4. no allergy history of iodinated contrast medium Exclusion Criteria: Fitting any of the followings 1. pregnant or lactating woman 2. withdrawal of informed consent 3. no completion of CTU study 4. no established final diagnosis or follow up duration less than 6 months
40 Years - N/A
Accepts Healthy Volunteers
Li-Jen Wang, M.D., M.P.H., 886975365759, [email protected]
Chang Gung Memorial Hospital
Li-Jen Wang, M.D., M.P.H., Principal Investigator, Chang Gung Memorial Hospital