Clinical trial · Interventional
Prospective Trial for Examining Hematuria Using Computed Tomography
NCT04077359CI-TRIAL-00060691PROTEHCTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cyst | — | UNRESOLVED | — |
| Renal Stone | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- nephrographic phase CT
- description
- the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series
- interventionNames
- Diagnostic Test: CT
- type
- ACTIVE_COMPARATOR
- label
- gold standard
- description
- all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm
- interventionNames
- Diagnostic Test: CT
Primary outcomes (1)
- measure
- accuracy for detecting urothelial cell carcinomas
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.