Prospective Trial for Examining Hematuria Using Computed Tomography (PROTEHCT)

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).

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma; Urothelial Carcinoma; Renal Stone; Renal Cyst
• Intervention / Treatment: Diagnostic test: CT

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: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0524
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nephrographic phase CT; the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series	Diagnostic test: CT; the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
Active Comparator: gold standard; all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm	Diagnostic test: CT; the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
false negative rate	The difference in false negative rates	all examinations are evaluated immediately after the CT examination
false positive rate	The difference in false positive rates	all examinations are evaluated immediately after the CT examination
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
Area under the curve (AUC)	the difference in AUC of the two arms	all examinations are evaluated immediately after the CT examination
predictive values	The difference in the predictive values of the two arms	all examinations are evaluated immediately after the CT examination
Detection or urinary calculi	The difference in detection of the two arms	all examinations are evaluated immediately after the CT examination
Detection of Bosniak cyst	The difference in detection in the two arms	all examinations are evaluated immediately after the CT examination
Interobserver variability	The agreement and variability between primary and secondary readers	all examinations are evaluated immediately after the CT examination

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Erik Rud, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Hemorrhage; Urination Disorders; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Hematuria
• Other Study ID Numbers: 2019/395

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No