Prospective Trial for Examining Hematuria Using Computed Tomography (PROTEHCT)

University of Oslo (UIO)

Status: Completed

Conditions: Renal Stone; Urothelial Carcinoma; Renal Cyst; Renal Cell Carcinoma

Treatments: Diagnostic Test: CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04077359

2019/395

Details and patient eligibility

About

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).

Full 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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

nephrographic phase CT

Experimental group

Description:

the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series

Treatment:

Diagnostic Test: CT

gold standard

Active Comparator group

Description:

all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm

Treatment:

Diagnostic Test: CT