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RECRUITING Phase 2 ClinicalTrials.gov

Trop2-Targeted NIR-II Fluorescent Probe for Identifying Bladder Cancer in Ex Vivo Bladder Samples

Sponsor: Yunnan Cancer Hospital • ClinicalTrials.gov ID: NCT07848854

Registry updated: 2026-09-30
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Description

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.

Interventions

  • TTP-ICG fluorescent probe (Drug)
    After radical cystectomy, 50 mL TTP-ICG solution (20 μg/mL) is instilled into lumen of isolated bladder specimen for 3 minutes incubation. Then probe solution is drained; bladder lumen washed 3 times by normal saline(30 seconds per time). Near-infrared-II fluorescence imaging is performed on inner bladder surface. Fluorescent highlighted lesions are harvested for pathological examination.

Eligibility criteria

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.

Conditions

Bladder Cancer (BC) Urothelial Carcinoma (UC)

Locations

  • Yunnan Cancer Hospital — Kunming, Yunnan, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record