Clinical trial · Observational
Confocal Laser Endomicroscopy in the Lower Urinary Tract
Feasibility of Confocal Laser Endomicroscopy in Bladder Cancer Diagnosis
- 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: Cystoscopy and cytology, the current 'gold standard' for detection and follow-up of primary and recurrent bladder cancer have some limitations. CLE, a high resolution imaging technique, that can be used combined with endo-urological procedures, seems promising to improve diagnosis of bladder cancer. The diagnostic accuracy of cystoscopic applied confocal laser endomicroscopy (CLE) still has to be defined. Objective: To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade and carcinoma in situ (CIS)) of the lower urinary tract. Primary objective: to develop descriptive image interpretation criteria and a classification of CLE images of bladder tissue through a review of prospectively obtained CLE videos from bladder tissue correlated with histopathology. Secondary objectives: * Assessing procedure related adverse events of CLE * Assessing technical feasibility of CLE * To develop a CLE image atlas for urothelium of the lower urinary tract (normal, benign, low-grade or high-grade and CIS)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Neoplasm | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| 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
- Confocal laser endomicroscopy characteristics of urothelium of the lower urinary tract
- timeFrame
- 1.5 years
- description
- Qualitatively correlating CLE images to histopathology to define CLE characteristics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>18 years old * Bladder tumor(s) * Candidate for TURB * Signed informed consent Exclusion Criteria: * Patients \<18 years old * Patients with known allergy for fluorescein * Possible pregnancy or lactating women * 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