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RECRUITING
NCT07848854
PHASE2

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

Sponsor: Yunnan Cancer Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-08-01

Completion Date

2027-08-30

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DRUG

TTP-ICG fluorescent probe

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.

Locations (1)

Yunnan Cancer Hospital

Kunming, Yunnan, China