Trop2-targeted NIR-II probe to identify bladder cancer in ex vivo samples
Official title: Trop2-Targeted NIR-II Fluorescent Probe for Identifying Bladder Cancer in Ex Vivo Bladder Samples
Run by Yunnan Cancer Hospital · NCT07848854 · Data updated 2026-11-12
A phase 2 study tests whether a Trop2-targeted NIR-II fluorescent probe can highlight bladder cancer lesions on ex vivo bladder tissue from patients undergoing radical cystectomy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Yunnan Cancer Hospital Academic / other |
| Locations | 1 site (Kunming, Yunnan) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | July 30, 2027 |
| Study ends | August 30, 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07848854 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with suspected or confirmed bladder tumors scheduled for radical cystectomy who can provide informed consent.
✕Probably not a fit
Patients with non-bladder cancers, significant comorbidities, or those not undergoing cystectomy may not benefit from this ex vivo imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, single-arm phase 2 study evaluates a Trop2-targeted NIR-II fluorescent probe (TTP-ICG) applied to ex vivo bladder specimens. After a short 3-minute incubation and washing, near-infrared fluorescence imaging is used to identify suspicious lesions, which are then confirmed by histopathology. The study aims to measure sensitivity and specificity for detecting malignant lesions and to examine the relationship between fluorescence intensity and pathology. Thirty patients with suspected or confirmed bladder tumors are enrolled. Outcomes will inform whether this imaging approach can improve detection of occult or small lesions beyond standard white-light inspection.
Why it matters
Potential benefit: If successful, the imaging probe could improve detection of bladder cancer lesions and potentially reduce recurrence by guiding more complete surgical assessment.
How similar studies have gone: Previous work supports Trop2 as a tumor biomarker and similar fluorescence-guided imaging approaches have shown promise in oncology, though this exact ex vivo NIR-II probe method is investigational.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Yunnan Cancer Hospital
Kunming, Yunnan, China Recruiting
Study contacts
- Study coordinator: Shengjie Lin, Doctor of Medicine
- Email: Linshengjie1128@163.com
- Phone: 86+17850112800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.