Clinical trial · Interventional
Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors
Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors
- 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)
Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.
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 |
|---|---|---|---|
| Cancer of Urinary Tract | Malignant Urinary Tract Neoplasm | ALIAS | 0.90 |
| Hematuria | — | UNRESOLVED | — |
| Nephrolithiasis | — | UNRESOLVED | — |
| Ureteropelvic Junction Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser confocal microscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laser confocal microscopy
- description
- Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will follow a laser confocal microscopy procedure.
- interventionNames
- Device: Laser confocal microscopy
Primary outcomes (1)
- measure
- Diagnostic relevance of laser confocal microscopy compared to the cytological and histological data, during reno-ureteroscopy according to Chang's reference criteria
- timeFrame
- 24 months
- description
- According to Chang's reference criteria, we will define the urothelial microarchitecture (normal, papillary, inflammatory, low grade lesion, high grade lesion, in situ carcinoma). The diagnostic relevance of the MCL (absence or presence of the lesion) will be compare to the reference tests calculating sensibility, specificity and predictive values
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any legally adult fully informed patient who consent to participate to the study * Patient followed by the Urology Department * Indication for a diagnosis or treatment reno-ureteroscopy * Coverage of the social insurance Exclusion Criteria: * Minor Patient * Pregnancy or breast feeding * Concomitant treatment (for example beta-blocker) * Contra-indication to general anaesthesia * Hypersensitivity to sodium fluorescein * Medical history of cardio-pulmonary disease (myocardial infarction, cardiovascular event, bronchospasm ...) due to fluorescein instillation * Medical history of asthma or allergy due to fluorescein instillation
References
Publications (1)
- RESULTMarien A, Rock A, Maadarani KE, Francois C, Gosset P, Mauroy B, Bonnal JL. Urothelial Tumors and Dual-Band Imaging: A New Concept in Confocal Laser Endomicroscopy. J Endourol. 2017 May;31(5):538-544. doi: 10.1089/end.2016.0892. Epub 2017 Mar 22. PMID 28326794