Prospective Trial for Examining Hematuria Using Computed Tomography
- Conditions
- Urothelial CarcinomaRenal Cell CarcinomaRenal StoneRenal Cyst
- Interventions
- Diagnostic Test: CT
- Registration Number
- NCT04077359
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Asymptomatic macroscopic hematuria referred to CTU before cystoscopy
- >18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gold standard CT all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm nephrographic phase CT CT the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series
- Primary Outcome Measures
Name Time Method accuracy for detecting urothelial cell carcinomas all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year 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%
- Secondary Outcome Measures
Name Time Method false negative rate all examinations are evaluated immediately after the CT examination The difference in false negative rates
false positive rate all examinations are evaluated immediately after the CT examination The difference in false positive rates
Area under the curve (AUC) all examinations are evaluated immediately after the CT examination the difference in AUC of the two arms
Detection or urinary calculi all examinations are evaluated immediately after the CT examination The difference in detection of the two arms
Detection of Bosniak cyst all examinations are evaluated immediately after the CT examination The difference in detection in the two arms
renal cell carcinoma detection rates all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year The detection rates in the two arms
predictive values all examinations are evaluated immediately after the CT examination The difference in the predictive values of the two arms
Interobserver variability all examinations are evaluated immediately after the CT examination The agreement and variability between primary and secondary readers
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway