Spots Global Cancer Trial Database for Prospective Trial for Examining Hematuria Using Computed Tomography

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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