Trop2-targeting NIR-II Molecular Probe for Guided Identification of Non-Muscle-Invasive Bladder Cancer

NCT06972771 — Recruiting, 40 participants, Yunnan Cancer Hospital

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Trop2-targeting the Second Near-Infrared Fluorescence(NIR-II ) Molecular Probe for Guided Identification of Non-Muscle-Invasive Bladder Cancer

Registry	NCT06972771
Status	Recruiting
Study type	Observational
Enrollment	40 (Estimated)
Sponsor	Yunnan Cancer Hospital (Other)
Conditions	Bladder Cancer (BC)
Interventions	TTP-ICG incubation solution (Diagnostic test)
Dates	start 2025-01-17, primary completion 2026-12-30 (estimated), completion 2027-01-30 (estimated), first posted 2025-05-15, last updated 2026-09-02
Locations	1 site in China

-Summary

Bladder cancer ranks as the fourth most common malignancy among males the United States . Approximately 75% of patients present with non-muscle-invasive bladder cancer (NMIBC). For the diagnosis and treatment of NMIBC, current guidelines widely recommend white light cystoscopy (WLC) and transurethral resection of the bladder tumor (TURBT). Unfortunately, up to 70% of patients with NMIBC experience intravesical recurrence within five years of their initial treatment. The high recurrence rates necessitate long-term surveillance for most NMIBC patients, making it one of the most costly malignancies to manage. In fact, a higher risk of disease recurrence is also associated with the now widely used WLC and TURBT, which cause false-negative investigations with an inadequate resection or residual tumor, especially when urothelial tumors present as carcinoma in situ or multiple.

Indocyanine green (ICG)-based the second near-infrared (NIR-II) fluorescence imaging offers real-time visualization during surgery, potentially reducing residual tumor. Herein, the investigators will introduce a novel NIR-II probe, TTP-ICG, based on a Trop2-targeting peptide (TTP) and an approach which enables differentiation between cancer and para-cancer . In brief, tissues will be soaked in TTP-ICG after resection, and their histological characterization will be determined under NIR-II fluorescence imaging. Pathological confirmation will further validate our approach.

To explore the conditions for the future in vivo real-time identification of NMIBC during NIR-II fluorescence -guided surgery.

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+Detailed description

After patient enrollment, surgical treatment will be administered based on clinical diagnosis and treatment. Following the surgery, excised tissues will undergo incubation with TTP-ICG following this specific procedure:

1. Preparation of the incubation solution: TTP-ICG will be dissolved in phosphate-buffered saline (PBS) at room temperature in the dark at a concentration of 20 μg/mL.
2. Incubation of the cancer and adjacent tissues: The excised tissues will be immersed and gently agitated in the incubation solution for 3 minutes. Subsequently, they will be rinsed with PBST buffer (PBS with Tween 20) for 5 minutes and dried using absorbent paper.
3. Acquisition of NIR-II images: NIR-II images and fluorescent intensities will be captured using the " Digital Precision Medicine (DPM) " NIR-II system, optimized with appropriate parameters.
4. Pathological diagnosis and data analysis: Hematoxylin and eosin (H\&E) staining, along with immuno-histochemistry (IHC) , will be performed. The subsequent correlation between pathological characterization and fluorescent information will be further analyzed.

+Arms and interventions

Arm	Type	Interventions	Description
TTP-ICG incubation		Diagnostic Test: TTP-ICG incubation solution	The resected clinical specimens will be completely soaked in the TTP-ICG incubation solution (20 μg/mL) for 3 minutes, followed by 5 minutes of rinsing with PBST buffer and drying with absorbent paper. The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed.

TTP-ICG incubation solution (Diagnostic test): Clinical specimens will be incubated with TTP-ICG solution.

+Outcome measures

Primary outcomes

Differentiation of bladder cancer and para-cancer tissues [2 Years]: NIR-II fluorescence intensity of bladder cancer and para-cancer tissues after TTP-ICG incubation : NIR-II fluorescence imaging acquisition and intensity analysis was conducted using the Digital Precision Medicine (DPM) NIR-II system. Following initial system parameter calibration and spatial scaling, fluorescence signals were captured and quantitatively analyzed to determine whether the tissue is benign or malignant through proprietary diagnostic algorithms.

Secondary outcomes

Correlation between NIR-Ⅱ fluorescence and pathological diagnosis of tissues [2 years]: Examination of H\&E pathological results and Trop2 IHC results in resected tissue.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Adult patients between 18-80 years of age
* Patients with suspected bladder cancer scheduled to undergo surgical intervention.
* Good operative candidate
* Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

* Patients unable to participate in the consent process
* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
* Other conditions that the researcher considers inappropriate to participate in the study

+Locations (1)

Facility	City	Country	Status
Yunnan Cancer Hospital	Kunming, Yunnan	China	Recruiting