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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2021
  • participants needed
    352
  • sponsor
    Chang Gung Memorial Hospital
Updated on 23 January 2021

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+Z/2)^2/(-||)^2 [p1(1-p1)/k+p1(1-p2)]

=0.05, =0.2, =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.

Details
Condition Transitional cell carcinoma, Urothelial Carcinoma
Treatment Urinary malignancy
Clinical Study IdentifierNCT04113603
SponsorChang Gung Memorial Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Urothelial Carcinoma or Transitional cell carcinoma?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note