Prospective Trial for Examining Hematuria Using Computed Tomography

Prospective Trial for Examining Hematuria Using Computed Tomography

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

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