Clinical trial · Interventional
Trop2-Targeted NIR-II Fluorescent Probe for Identifying Bladder Cancer in Ex Vivo Bladder Samples
- Source
- ClinicalTrials.gov
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
Up to 30% of non-muscle-invasive bladder cancer (NMIBC) lesions may be missed by standard white-light cystoscopy, resulting in high tumor recurrence rate. This is a single-center, single-arm, phase 2 prospective study. We apply Trop2-targeted NIR-II fluorescent probe TTP-ICG with rapid incubation to ex vivo bladder specimens from patients undergoing radical cystectomy. Near-infrared fluorescence imaging is performed after short-time incubation and washing. Using histopathology as gold standard, we evaluate the sensitivity, specificity of this imaging system for identifying bladder cancer lesions, and analyze correlation between fluorescence intensity and pathological diagnosis. 30 subjects will be enrolled.
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 (BC) | Malignant Bladder Neoplasm | CURATED_EXACT | 0.85 |
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TTP-ICG fluorescent probe | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TTP-ICG ex-vivo rapid incubation fluorescence imaging
- interventionNames
- Drug: TTP-ICG fluorescent probe
Primary outcomes (4)
- measure
- Diagnostic Sensitivity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
- timeFrame
- Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
- description
- Sensitivity of TTP-ICG rapid-incubation NIR-II fluorescence imaging to identify malignant bladder lesions in ex-vivo radical-cystectomy specimens. Histopathology serves as gold-standard reference. Sensitivity = true-positive / (true-positive + false-negative).
- measure
- Diagnostic Specificity of ex-vivo Trop2-targeted NIR-II fluorescence imaging for detecting malignant bladder lesions
- timeFrame
- Within 7 days after collection of ex-vivo bladder specimen, after histopathology report available
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Suspected or confirmed bladder tumor patients who are scheduled to undergo radical cystectomy. 2. Able to provide written informed consent and comply with study protocol. Exclusion Criteria: 1. Suffering from other invasive malignant tumors. 2. With severe comorbidities including congenital malformation, acute active inflammation, cachexia, myocardial infarction or stroke within past 6 months, severe hepatic or renal insufficiency. 3. Pregnant or lactating female subjects. 4. Participated in another clinical trial within past 30 days.
References
Publications (0)
Data not yet available