Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography
Primary Purpose
Urothelial Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Urinary malignancy
Sponsored by
About this trial
This is an interventional other trial for Urothelial Carcinoma
Eligibility Criteria
Inclusion Criteria: 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
Sites / Locations
- Li-Jen WangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A_Single bolus
B_Split bolus
Arm Description
Single bolus computed tomography urography (CTU)
Split bolus computed tomography urography (CTU)
Outcomes
Primary Outcome Measures
diagnostic values of urothelial carcinoma
sensitivity, specificity, accuracy, area under ROC
Secondary Outcome Measures
radiation dose
radiation dose of single bolus versus split bolus CTU
Full Information
NCT ID
NCT04113603
First Posted
October 1, 2019
Last Updated
August 4, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04113603
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A_Single bolus
Arm Type
Experimental
Arm Description
Single bolus computed tomography urography (CTU)
Arm Title
B_Split bolus
Arm Type
Experimental
Arm Description
Split bolus computed tomography urography (CTU)
Intervention Type
Diagnostic Test
Intervention Name(s)
Urinary malignancy
Intervention Description
Single bolus three phase CTU
Primary Outcome Measure Information:
Title
diagnostic values of urothelial carcinoma
Description
sensitivity, specificity, accuracy, area under ROC
Time Frame
3 years
Secondary Outcome Measure Information:
Title
radiation dose
Description
radiation dose of single bolus versus split bolus CTU
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
diagnostic values of other urinary tract diseases
Description
sensitivity, specificity and accuracy
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Jen Wang, M.D., M.P.H.
Phone
886975365759
Email
lijenwang0918@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yon-Cheong Wong, M.D.
Phone
886975365758
Email
wongyoncheong@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Jen Wang, M.D., M.P.H.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li-Jen Wang
City
Taoyuan
State/Province
Ta
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Jen Wang, M.D., M.P.H.
Phone
886975365759
Email
lijenwang0918@gmail.com
First Name & Middle Initial & Last Name & Degree
Yon-Cheong Wong, M.D.
Phone
886975365758
Email
wongyoncheong@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Plan to make individual participant data
Learn more about this trial
Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography
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