PROTEHCT: Prospective Trial for Examining Hematuria Using Computed Tomography
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.
Study type: Prospective clinical trial
Study design: Two 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 false negative rates in 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- false negative rates for detecting urothelial cell carcinomas [all examinations are evaluated immediately after the CT examination]
the false negative rate in the experimental arm will not exceed the false negative rate of the control-arm defined by the non-inferiority limit of 7.5%
Secondary Outcome Measures
- renal cell carcinoma detection rates [all examinations are evaluated immediately after the CT examination]
The detection rates in the two arms
- Area under the curve (AUC) [all examinations are evaluated immediately after the CT examination]
the difference in AUC of the two arms
- predictive values [all examinations are evaluated immediately after the CT examination]
The difference in the predictive values of the two arms
- Detection or urinary calculi [all examinations are evaluated immediately after the CT examination]
The difference in detection of the two arms
- Detection of Bosniak cyst [all examinations are evaluated immediately after the CT examination]
The difference in detection in the two arms
- Interobserver variability [all examinations are evaluated immediately after the CT examination]
The agreement and variability between primary and secondary readers
Eligibility Criteria
Criteria
Inclusion Criteria:
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Asymptomatic macroscopic hematuria referred to CTU before cystoscopy
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18 years old
Exclusion Criteria:
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Symptomatic urinary tract infection relieved by antibiotics
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Patients referred to CTU after cystoscopy
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Cystoscopy within the last 6 months
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Symptomatic stone disease
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Macroscopic hematuria after recent catherization or instrumentation
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Microscopic hematuria
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Previous history of Urothelial cell carcinoma
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Known staghorn calculi
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Allergy to iodine contrast media
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Impaired renal function (eGFR < 30m/min/1.73m2)
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Unable to provide consent for any reason
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For any reason, do not wish to participate in the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Oslo University Hospital | Oslo | Norway | 0524 |
Sponsors and Collaborators
- Oslo University Hospital
Investigators
- Principal Investigator: Erik Rud, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019/395