Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography

Urothelial Carcinoma Clinical Trial

Official title:

Comparison of Diagnostic Performance of Urothelial Carcinomas Between Single-bolus and Split-bolus Computed Tomography Urography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04113603
• Other study ID #: 201701984A3
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 352
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Diagnostic Test:
• Urinary malignancy
Single bolus three phase CTU

Locations

Country	Name	City	State
Taiwan	Li-Jen Wang	Taoyuan	Ta

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	diagnostic values of other urinary tract diseases	sensitivity, specificity and accuracy	3 years
Primary	diagnostic values of urothelial carcinoma	sensitivity, specificity, accuracy, area under ROC	3 years
Secondary	radiation dose	radiation dose of single bolus versus split bolus CTU	3 years