Clinical trial NCT04077359: Prospective Trial for Examining Hematuria Using Computed Tomography
Official title: Prospective Trial for Examining Hematuria Using Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urothelial Carcinoma
Renal Cell Carcinoma
Renal Cyst
Renal Stone
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: accuracy for detecting urothelial cell carcinomas
timeFrame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year
Secondary outcomes:
measure: false negative rate
timeFrame: all examinations are evaluated immediately after the CT examination
measure: false positive rate
timeFrame: all examinations are evaluated immediately after the CT examination
measure: renal cell carcinoma detection rates
timeFrame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year
measure: Area under the curve (AUC)
timeFrame: all examinations are evaluated immediately after the CT examination
measure: predictive values
timeFrame: all examinations are evaluated immediately after the CT examination
measure: Detection or urinary calculi
timeFrame: all examinations are evaluated immediately after the CT examination
measure: Detection of Bosniak cyst
timeFrame: all examinations are evaluated immediately after the CT examination
measure: Interobserver variability
timeFrame: all examinations are evaluated immediately after the CT examination
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Erik Rud
role: PRINCIPAL_INVESTIGATOR
References: