Renal Cell Carcinoma, Renal Cyst, Renal Stone, Urothelial Carcinoma
Conditions
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
Interventions
DIAGNOSTIC_TESTCT
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
Sponsors
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
one investigator evaluates the experimental arm a second investigator evaluates the control arm without knowledge of the other
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| false positive rate | all examinations are evaluated immediately after the CT examination | The difference in false positive rates |
| 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 |
| Area under the curve (AUC) | all examinations are evaluated immediately after the CT examination | the difference in AUC of the two arms |
| false negative rate | all examinations are evaluated immediately after the CT examination | The difference in false negative rates |
| 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 |
| Interobserver variability | all examinations are evaluated immediately after the CT examination | The agreement and variability between primary and secondary readers |
| predictive values | all examinations are evaluated immediately after the CT examination | The difference in the predictive values of the two arms |
Countries
Norway
Outcome results
None listed