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

NCT06972771 | Recruiting DMC

• 1 other identifier: KYLX2024-304
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Muscle-Invasive Bladder Cancer

Keywords

Trop2; NIR-II; Non-Muscle-Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Differentiation of bladder cancer and para-cancer tissues

  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.

  6 months

Secondary Outcomes (1)

• Correlation between NIR-Ⅱ fluorescence and pathological diagnosis of tissues

  6 months

Study Arms (1)

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.

Diagnostic Test: TTP-ICG incubation solution

Interventions

TTP-ICG incubation solution DIAGNOSTIC_TEST

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

TTP-ICG incubation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators plan to enroll 30 patients, who have been suspected non-muscle-invasive bladder cancer scheduled to undergo surgical intervention. Following the surgery, the resected tissues will be incubated with the TTP-ICG solution, and NIR-II fluorescence signals from the tissues will be collected.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Shengjie Lin, Doctor of Medicine

CONTACT

86+18359010705; linshengjie1128@163.com

Jingwen Bai, Doctor of Medicine

CONTACT

86+13411961052; baijingwen666@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: January 17, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-04

Locations

CN (1)