NCT04077359

Prospective Trial for Examining Hematuria Using Computed Tomography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Urothelial Carcinoma
• Renal Cell Carcinoma
• Renal Cyst
• Renal Stone

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT	the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.

Timeline

• Start date: 2019-09-15
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-09-04
• Last updated: 2022-09-06

Locations

1 site across 1 country: Norway