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.
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
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
The investigators plan to enroll 40 patients, who have been suspected 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.
Case-only
Prospective
TTP-ICG incubation solution
Diagnostic testClinical specimens will be incubated with TTP-ICG solution.
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.
Correlation between NIR-Ⅱ fluorescence and pathological diagnosis of tissues
Examination of H\&E pathological results and Trop2 IHC results in resected tissue.
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