Clinical trial · Interventional
Confocal Laser Endomicroscopy During TransUrethral Resection for Improving BC Diagnosis and Treatment
Confocal Laser Endomicroscopy During TransUrethral Resection for Improving Bladder Cancer Diagnosis and Treatment
- 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)
A prospective monocenter diagnostic accuracy study of Confocal Laser Endomicroscopy (CLE) for Bladder Cancer(BC) to assess two primary objectives: 1. The diagnostic accuracy of flexible probe-based confocal laser endomicroscopy (CLE) compared to histopathology of the resection specimen. 2. The diagnostic accuracy of CLE-based assessment of the surgical radicality of the resection bed (radical vs irradical) in comparison with histopathology of a biopsy of the resection bed. All patients with a papillary bladder tumor on cystoscopy will be included in this trial.
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 Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| CLE | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal Laser Endomicroscopy (CLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Diagnostic accuracy of flexible-probe based CLE(pCLE) for the diagnosis of urothelial carcinoma of the bladder (UCB)
- timeFrame
- Consensus panel within 12 months of start of study.
- description
- Diagnostic accuracy (sensitivity, specificity, negative predictive value and positive predictive value) of flexible probe based CLE for the diagnosis (low-grade malignant, high-grade malignant) of urothelial carcinoma of the bladder.
- measure
- Diagnostic potential of probe based CLE for assessment of surgical radicality after transurethral resection of a bladder tumour (TURBT).
- timeFrame
- Consensus panel within 12 months of start of study.
- description
- To investigate the diagnostic potential of CLE for the assessment of the surgical radicality (residual tumor/no residual tumor) after TURBT.
- measure
- Diagnostic potential of probe based CLE for assessment of depth of resection after transurethral resection of a bladder tumour (TURBT).
- timeFrame
- Consensus panel within 12 months of start of study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Display a papillary bladder tumor on cystoscopy. * \>18 years of age. * Has given written informed consent. Exclusion Criteria: * Patients with a known allergy to fluorescein. * Pregnancy or lactating women.
References
Publications (0)
Data not yet available