Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-04 @ 7:06 PM
Study NCT ID:
NCT04077359
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2019-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Trial for Examining Hematuria Using Computed Tomography
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Prospective Trial for Examining Hematuria Using Computed Tomography
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTEHCT
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: