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

Brief Title

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

Official Title

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

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 .

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 Type

Interventional

Primary Outcome

diagnostic values of urothelial carcinoma

Secondary Outcome

 radiation dose

Condition

Urothelial Carcinoma

Intervention

Urinary malignancy

Study Arms / Comparison Groups

 A_Single bolus

Description:  Single bolus computed tomography urography (CTU)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

Start Date

June 1, 2019

Completion Date

July 31, 2021

Primary Completion Date

July 31, 2021

Eligibility Criteria

        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

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Li-Jen Wang, M.D., M.P.H., 886975365759, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT04113603

Organization ID

201701984A3

Responsible Party

Sponsor

Study Sponsor

Chang Gung Memorial Hospital

Study Sponsor

Li-Jen Wang, M.D., M.P.H., Principal Investigator, Chang Gung Memorial Hospital

Verification Date

July 2021