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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06972771
Enrollment
40
Registered
2025-05-15
Start date
2025-01-17
Completion date
2027-01-30
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer (BC)

Keywords

Trop2, NIR-II, Bladder Cancer(BC)

Brief 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.

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.

Interventions

Clinical specimens will be incubated with TTP-ICG solution.

Sponsors

Yunnan Cancer Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differentiation of bladder cancer and para-cancer tissues2 YearsNIR-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

MeasureTime frameDescription
Correlation between NIR-Ⅱ fluorescence and pathological diagnosis of tissues2 yearsExamination of H\&E pathological results and Trop2 IHC results in resected tissue.

Countries

China

Contacts

CONTACTShengjie Lin, Doctor of Medicine
linshengjie1128@163.com86+18359010705
CONTACTJingwen Bai, Doctor of Medicine
baijingwen666@126.com86+13411961052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026