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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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Oslo University Hospital
Oslo, Norway
Start Date
September 15, 2019
Primary Completion Date
July 1, 2021
Completion Date
July 1, 2021
Last Updated
September 6, 2022
300
ACTUAL participants
CT
DIAGNOSTIC_TEST
Lead Sponsor
Oslo University Hospital
NCT07061964
NCT07485114
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