Clinical trial · Observational
CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma
A Prospective In-Vivo Human Pilot Study to Assess Confocal Laser Endomicroscopy Characteristics of Upper Tract Urothelial Carcinoma
- 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)
Rationale: Initial evaluation usually consists of cross sectional imaging of the urinary tract. When a suspect lesion is seen, an ureterorenoscopy is planned to visualize the lesion and to collect tissue for histopathology. These techniques are considered to be the gold standard in diagnosis of UTUC. CLE, a high resolution imaging technique that can be used in combination with endo-urological procedures, seems promising to improve diagnosis of urothelial cancer. CLE image characteristics for UTUC still have to be defined. Objective: With this IDEAL stage 2b explorative pilot study the investigators aim to assess in-vivo CLE image characteristics of normal urothelium, benign urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract by qualitatively comparing CLE images with both histopathology from diagnostic biopsies and pathology from the therapeutic radical nephroureterectomy. Secondary objectives are the development of an imaging atlas and to assess the technical feasibility and procedure related adverse events of CLE.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ureter Cancer | Malignant Ureter Neoplasm | CURATED_BROADER | 0.80 |
| Urinary Tract Cancer | Malignant Urinary Tract Neoplasm | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- In-vivo CLE measurements of normal urothelium and urothelial carcinoma (low-grade, high-grade or CIS) of the upper urinary tract
- timeFrame
- 3 years
- description
- The CLE measurements are qualitatively correlated to the corresponding histopathology
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>18 years * Suspect upper urinary tract urothelial carcinoma * Scheduled for diagnostic URS * Signed informed consent Exclusion Criteria: * Patients \<18 years * Patients with known allergy for fluorescein * Possible pregnancy or lactating women * Patients not eligible for radical treatment of UTUC * No signed informed consent
References
Publications (1)
- DERIVEDLiem EI, Freund JE, Baard J, de Bruin DM, Laguna Pes MP, Savci-Heijink CD, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Confocal Laser Endomicroscopy for the Diagnosis of Urothelial Carcinoma in the Bladder and the Upper Urinary Tract: Protocols for Two Prospective Explorative Studies. JMIR Res Protoc. 2018 Feb 7;7(2):e34. doi: 10.2196/resprot.8862. PMID 29415874