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Prospective Trial for Examining Hematuria Using Computed Tomography (PROTEHCT)

Primary Purpose

Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cyst

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CT
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nephrographic phase CT

gold standard

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

false negative rate
The difference in false negative rates
false positive rate
The difference in false positive rates
renal cell carcinoma detection rates
The detection rates in the two arms
Area under the curve (AUC)
the difference in AUC of the two arms
predictive values
The difference in the predictive values of the two arms
Detection or urinary calculi
The difference in detection of the two arms
Detection of Bosniak cyst
The difference in detection in the two arms
Interobserver variability
The agreement and variability between primary and secondary readers

Full Information

First Posted
August 30, 2019
Last Updated
September 1, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04077359
Brief Title
Prospective Trial for Examining Hematuria Using Computed Tomography
Acronym
PROTEHCT
Official Title
Prospective Trial for Examining Hematuria Using Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cyst, Renal Stone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Masking Description
one investigator evaluates the experimental arm a second investigator evaluates the control arm without knowledge of the other
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nephrographic phase CT
Arm Type
Experimental
Arm Description
the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series
Arm Title
gold standard
Arm Type
Active Comparator
Arm Description
all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm
Intervention Type
Diagnostic Test
Intervention Name(s)
CT
Intervention Description
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
Primary Outcome Measure Information:
Title
accuracy for detecting urothelial cell carcinomas
Description
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%
Time Frame
all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year
Secondary Outcome Measure Information:
Title
false negative rate
Description
The difference in false negative rates
Time Frame
all examinations are evaluated immediately after the CT examination
Title
false positive rate
Description
The difference in false positive rates
Time Frame
all examinations are evaluated immediately after the CT examination
Title
renal cell carcinoma detection rates
Description
The detection rates in the two arms
Time Frame
all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year
Title
Area under the curve (AUC)
Description
the difference in AUC of the two arms
Time Frame
all examinations are evaluated immediately after the CT examination
Title
predictive values
Description
The difference in the predictive values of the two arms
Time Frame
all examinations are evaluated immediately after the CT examination
Title
Detection or urinary calculi
Description
The difference in detection of the two arms
Time Frame
all examinations are evaluated immediately after the CT examination
Title
Detection of Bosniak cyst
Description
The difference in detection in the two arms
Time Frame
all examinations are evaluated immediately after the CT examination
Title
Interobserver variability
Description
The agreement and variability between primary and secondary readers
Time Frame
all examinations are evaluated immediately after the CT examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Rud
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0524
Country
Norway

12. IPD Sharing Statement

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Prospective Trial for Examining Hematuria Using Computed Tomography

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