Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography
Study Details
Study Description
Brief Summary
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A_Single bolus Single bolus computed tomography urography (CTU) |
Diagnostic Test: Urinary malignancy
Single bolus three phase CTU
|
| Experimental: B_Split bolus Split bolus computed tomography urography (CTU) |
Diagnostic Test: Urinary malignancy
Single bolus three phase CTU
|
Outcome Measures
Primary Outcome Measures
- diagnostic values of urothelial carcinoma [3 years]
sensitivity, specificity, accuracy, area under ROC
Secondary Outcome Measures
- radiation dose [3 years]
radiation dose of single bolus versus split bolus CTU
Other Outcome Measures
- diagnostic values of other urinary tract diseases [3 years]
sensitivity, specificity and accuracy
Eligibility Criteria
Criteria
Inclusion Criteria: Fitting all of the followings
-
age ≥ 40 years old
-
presenting with gross hematuria or having a history of urothelial carcinomas
-
normal renal function (i.e.: estimated glomerular filtration rate ≧ 60 mL/min/1.73 m2)
-
no allergy history of iodinated contrast medium
Exclusion Criteria: Fitting any of the followings
-
pregnant or lactating woman
-
withdrawal of informed consent
-
no completion of CTU study
-
no established final diagnosis or follow up duration less than 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Li-Jen Wang | Taoyuan | Ta | Taiwan | 333 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Li-Jen Wang, M.D., M.P.H., Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201701984A3