The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control).
Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine. Study type: Prospective clinical trial Study design: One sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit. Investigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm) Objective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase CT (control). Primary endpoints: The difference in accuracy between the experimental- and control arm. there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm Sample size: 250 patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
Oslo University Hospital
Oslo, Norway
accuracy for detecting urothelial cell carcinomas
the accuracy of the experimental arm will not be worse than the accuracy of the control CT by a margin of more than 7.5%
Time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year
false negative rate
The difference in false negative rates
Time frame: all examinations are evaluated immediately after the CT examination
false positive rate
The difference in false positive rates
Time frame: all examinations are evaluated immediately after the CT examination
renal cell carcinoma detection rates
The detection rates in the two arms
Time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year
Area under the curve (AUC)
the difference in AUC of the two arms
Time frame: all examinations are evaluated immediately after the CT examination
predictive values
The difference in the predictive values of the two arms
Time frame: all examinations are evaluated immediately after the CT examination
Detection or urinary calculi
The difference in detection of the two arms
Time frame: all examinations are evaluated immediately after the CT examination
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Detection of Bosniak cyst
The difference in detection in the two arms
Time frame: all examinations are evaluated immediately after the CT examination
Interobserver variability
The agreement and variability between primary and secondary readers
Time frame: all examinations are evaluated immediately after the CT examination