Prospective Trial for Examining Hematuria Using Computed Tomography
NCT ID: NCT04077359
Last Updated: 2022-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
300 participants
INTERVENTIONAL
2019-09-15
2021-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition
NCT04110574
MR Urography vs CT Urography
NCT02606513
Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic
NCT06535711
Influence of Diuresis Timing (F+0 Vs F-15) on 99m Tc DTPA Renography for the Diagnosis of Suspected Obstructive Uropathy
NCT04564469
Low Tube Voltage Computed Tomographic (CT) Urography Using Low Concentration Iodine Contrast Agent
NCT01855204
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
nephrographic phase CT
the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series
CT
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
gold standard
all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm
CT
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CT
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \>18 years old
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oslo University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Erik Rud
Consulting radiologist, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Erik Rud
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oslo University Hospital
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019/395
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.