Clinical trial · Observational
Microscopic-spectroscopic Examination for Urothelial Tissue Characterization
NCT04310813CI-TRIAL-00044106MSUTcompletedClinicalTrials.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)
To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis
Conditions
Conditions (1)
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 Tumor | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal spectroscopic analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Endoscopic urologic patients
- description
- Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures.
- interventionNames
- Diagnostic Test: Multimodal spectroscopic analysis
Primary outcomes (1)
- measure
- diagnostic concordance
- timeFrame
- 30 minutes from resection
- description
- concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Secondary outcomes (2)
- measure
- grading concordance
- timeFrame
- 30 minutes from resection
- description
- concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * willingness to participate, * legal age, * full capacity to sign informed consent * eligibility for each surgical operation according to the best clinical practice and the urological guidelines Exclusion Criteria: * concomitant use of Hexaminolevulinate (Hexvix®) * concomitant ongoing UTIs, * concomitant bladder stone presence, * recent catheterization or persistent bladder catheterization at time of surgery, * concomitant presence of other pelvic cancer (both prostate, urethral, uterine), * previous chemotherapy or radiotherapy of the pelvis, * patient refusal at informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.