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RecruitingNCT06972771

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

Trial Parameters

ConditionNon-Muscle-Invasive Bladder Cancer
SponsorYunnan Cancer Hospital
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment30
SexALL
Min Age18 Years
Max Age80 Years
Start Date2025-01-17
Completion2025-10-30
Interventions
TTP-ICG incubation solution

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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.

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

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