PROTEHCT: Prospective Trial for Examining Hematuria Using Computed Tomography

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04077359
Collaborator
(none)
300
1
2
21.5
13.9

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
  • Diagnostic Test: CT
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

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two sample, paired, non-inferiority study with a 7.5% non-inferiority limit.Two sample, paired, non-inferiority study with a 7.5% non-inferiority limit.
Masking:
Single (Investigator)
Masking Description:
one investigator evaluates the experimental arm a second investigator evaluates the control arm without knowledge of the other
Primary Purpose:
Diagnostic
Official Title:
Prospective Trial for Examining Hematuria Using Computed Tomography
Actual Study Start Date :
Sep 15, 2019
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. renal cell carcinoma detection rates [all examinations are evaluated immediately after the CT examination]

    The detection rates in the two arms

  2. Area under the curve (AUC) [all examinations are evaluated immediately after the CT examination]

    the difference in AUC of the two arms

  3. predictive values [all examinations are evaluated immediately after the CT examination]

    The difference in the predictive values of the two arms

  4. Detection or urinary calculi [all examinations are evaluated immediately after the CT examination]

    The difference in detection of the two arms

  5. Detection of Bosniak cyst [all examinations are evaluated immediately after the CT examination]

    The difference in detection in the two arms

  6. Interobserver variability [all examinations are evaluated immediately after the CT examination]

    The agreement and variability between primary and secondary readers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Erik Rud, Consulting radiologist, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT04077359
Other Study ID Numbers:
  • 2019/395
First Posted:
Sep 4, 2019
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022