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Completed

NCT Number: NCT04077359

Prospective Trial for Examining Hematuria Using Computed Tomography

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).

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Key information

Conditions

Urothelial Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nephrolithiasis Renal Cell Carcinoma Renal Cyst Renal Stone Urogenital Diseases Urogenital Neoplasms Urolithiasis Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0524, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT

Diagnostic Test

the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.

Primary outcomes

  1. accuracy for detecting urothelial cell carcinomas

    Time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year

    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 outcomes

  1. false negative rate

    Time frame: all examinations are evaluated immediately after the CT examination

    The difference in false negative rates

  2. false positive rate

    Time frame: all examinations are evaluated immediately after the CT examination

    The difference in false positive rates

  3. renal cell carcinoma detection rates

    Time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year

    The detection rates in the two arms

  4. Area under the curve (AUC)

    Time frame: all examinations are evaluated immediately after the CT examination

    the difference in AUC of the two arms

  5. predictive values

    Time frame: all examinations are evaluated immediately after the CT examination

    The difference in the predictive values of the two arms

  6. Detection or urinary calculi

    Time frame: all examinations are evaluated immediately after the CT examination

    The difference in detection of the two arms

  7. Detection of Bosniak cyst

    Time frame: all examinations are evaluated immediately after the CT examination

    The difference in detection in the two arms

  8. Interobserver variability

    Time frame: all examinations are evaluated immediately after the CT examination

    The agreement and variability between primary and secondary readers

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: PROTEHCT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2019
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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