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

NCT04113603 | Active Not Recruiting

• 1 other identifier: 201701984A3
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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 .

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• diagnostic values of urothelial carcinoma

  sensitivity, specificity, accuracy, area under ROC

  3 years

Secondary Outcomes (1)

• radiation dose

  3 years

Other Outcomes (1)

• diagnostic values of other urinary tract diseases

  3 years

Study Arms (2)

A_Single bolus

EXPERIMENTAL

Single bolus computed tomography urography (CTU)

Diagnostic Test: Urinary malignancy

B_Split bolus

EXPERIMENTAL

Split bolus computed tomography urography (CTU)

Diagnostic Test: Urinary malignancy

Interventions

Urinary malignancy DIAGNOSTIC_TEST

Single bolus three phase CTU

A_Single bolus; B_Split bolus

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or lactating woman
• withdrawal of informed consent

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Li-Jen Wang

Taoyuan District, Ta, 333, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Li-Jen Wang, M.D., M.P.H.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Imaging Department Director

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)