NCT04113603

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

Active, enrolled NA Last updated 20 March 2026

What this trial tests

NA trial testing Urinary malignancy in Urothelial Carcinoma in 352 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2019

Primary endpoint
30 December 2026

30 December 2026

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	352
Start date	1 June 2019
Primary completion	30 December 2026
Estimated completion	30 December 2026
Sites	1 location across Taiwan

Drugs / interventions tested

• Urinary malignancy

Conditions studied

• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

Chang Gung Memorial Hospital

Who can join

40 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Split-bolus computed tomography urography (CTU) achieves more than half of radiation dose reduction in females and overweight patients than conventional single-bolus computed tomography urography.
   Wang LJ, Wong YC, Hwang YS, Pang ST, et al · · 2021 · cited 1× · PMID 34111709 · DOI 10.1016/j.tranon.2021.101151