Prospective Trial for Examining Hematuria Using Computed Tomography

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Prospective Trial for Examining Hematuria Using Computed Tomography

Conditions
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Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cyst, Renal Stone

Intervention / Treatment
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* Diagnostic Test: CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic macroscopic hematuria referred to CTU before cystoscopy >18 years old Exclusion Criteria: Symptomatic urinary tract infection relieved by antibiotics Patients referred to CTU after cystoscopy Cystoscopy within the last 6 months Symptomatic stone disease Macroscopic hematuria after recent catherization or instrumentation Microscopic hematuria Previous history of Urothelial cell carcinoma Known staghorn calculi Allergy to iodine contrast media Impaired renal function (eGFR < 30m/min/1.73m2) Unable to provide consent for any reason For any reason, do not wish to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nephrographic phase CT<br>the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series | Diagnostic Test: CT<br>* the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.<br>|
| Active Comparator: gold standard<br>all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm | Diagnostic Test: CT<br>* the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| false negative rate | The difference in false negative rates | all examinations are evaluated immediately after the CT examination | 
| false positive rate | The difference in false positive rates | all examinations are evaluated immediately after the CT examination | 
| renal cell carcinoma detection rates | The detection rates in the two arms | 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 | all examinations are evaluated immediately after the CT examination | 
| predictive values | The difference in the predictive values of the two arms | all examinations are evaluated immediately after the CT examination | 
| Detection or urinary calculi | The difference in detection of the two arms | all examinations are evaluated immediately after the CT examination | 
| Detection of Bosniak cyst | The difference in detection in the two arms | all examinations are evaluated immediately after the CT examination | 
| Interobserver variability | The agreement and variability between primary and secondary readers | all examinations are evaluated immediately after the CT examination |