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

NCT ID: NCT06972771

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2025-11-30

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, with varying concentrations (5, 10, 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, 5, or 10 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.

Conditions

Non-Muscle-Invasive Bladder Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

TTP-ICG incubation

The resected clinical specimens will be completely soaked in the TTP-ICG incubation solution (5, 10, 20 μg/mL) for 3, 5, or 10 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

Intervention Type: DIAGNOSTIC_TEST

Clinical specimens will be incubated with TTP-ICG with different concentrations and times.

Interventions

TTP-ICG incubation solution

Clinical specimens will be incubated with TTP-ICG with different concentrations and times.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adult patients between 18-80 years of age
• Patients with suspected non-muscle-invasive 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunnan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengjie Lin, Doctor of Medicine

Role: CONTACT

linshengjie1128@163.com

86+18359010705

Jingwen Bai, Doctor of Medicine

Role: CONTACT

baijingwen666@126.com

86+13411961052

Facility Contacts

Guojun Zhang, Doctor of Medicine

Role: primary

zhangguojun@kmmu.edu.cn

86+18850064298

Shengjie Lin, Doctor of Medicine

Role: backup

linshengjie1128@163.com

86+18359010705

Other Identifiers

KYLX2024-304

Identifier Type: -

Identifier Source: org_study_id