Prospective Trial for Examining Hematuria Using Computed Tomography

NCT04077359 | Completed DMC

• 1 other identifier: 2019/395
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Urothelial Carcinoma; Renal Cell Carcinoma; Renal Cyst; Renal Stone

Outcome Measures

Primary Outcomes (1)

• 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%

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

Secondary Outcomes (8)

• false negative rate

  all examinations are evaluated immediately after the CT examination

• false positive rate

  all examinations are evaluated immediately after the CT examination

• renal cell carcinoma detection rates

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

• Area under the curve (AUC)

  all examinations are evaluated immediately after the CT examination

• predictive values

  all examinations are evaluated immediately after the CT examination

Study Arms (2)

nephrographic phase CT

EXPERIMENTAL

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

Diagnostic Test: CT

gold standard

ACTIVE COMPARATOR

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

Diagnostic Test: CT

Interventions

CT DIAGNOSTIC_TEST

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

gold standard; nephrographic phase CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic macroscopic hematuria referred to CTU before cystoscopy
• \>18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0524, Norway

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Carcinoma, Renal Cell; Nephrolithiasis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urolithiasis

Study Officials

• Erik Rud

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: one investigator evaluates the experimental arm a second investigator evaluates the control arm without knowledge of the other
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulting radiologist, PhD

Model Details: One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 4, 2019
• Study Start: September 15, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

NO (1)