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

RecruitingPhase 2Ages 18 Years - 80 YearsAllYunnan Cancer Hospital
NCT07848854 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • TTP-ICG fluorescent probe
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Where

1 site
Yunnan Cancer Hospital
Kunming, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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