Prospective Trial for Examining Hematuria Using Computed Tomography

Renal Cell Carcinoma Clinical Trial

— PROTEHCT  

Official title:

Prospective Trial for Examining Hematuria Using Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077359
• Other study ID #: 2019/395
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Hematuria
• Renal Cell Carcinoma
• Renal Cyst
• Renal Stone
• Urothelial Carcinoma

Intervention

Diagnostic Test:
• CT
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy for detecting urothelial cell carcinomas	the accuracy of the experimental arm will not be worse than the accuracy of the control CT by a margin of more than 7.5%	all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year
Secondary	false negative rate	The difference in false negative rates	all examinations are evaluated immediately after the CT examination
Secondary	false positive rate	The difference in false positive rates	all examinations are evaluated immediately after the CT examination
Secondary	renal cell carcinoma detection rates	The detection rates in the two arms	all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year
Secondary	Area under the curve (AUC)	the difference in AUC of the two arms	all examinations are evaluated immediately after the CT examination
Secondary	predictive values	The difference in the predictive values of the two arms	all examinations are evaluated immediately after the CT examination
Secondary	Detection or urinary calculi	The difference in detection of the two arms	all examinations are evaluated immediately after the CT examination
Secondary	Detection of Bosniak cyst	The difference in detection in the two arms	all examinations are evaluated immediately after the CT examination
Secondary	Interobserver variability	The agreement and variability between primary and secondary readers	all examinations are evaluated immediately after the CT examination