Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer

Research Objective Taking Trop2, a specific target of bladder urothelial carcinoma, as the research basis, this study adopts a Trop2-targeted near-infrared (NIR) fluorescent probe combined with an intravesical rapid incubation imaging system to investigate the safety of this imaging system and whether it can improve the intraoperative identification accuracy of non-muscle invasive bladder cancer (NMIBC) (to assist surgeons in localizing NMIBC lesions intraoperatively). Research Procedures If you volunteer to participate in this study and sign the informed consent form, the study physicians will conduct pre-enrollment screening. You will be enrolled only if you meet the eligibility criteria. The study consists of three phases: Screening Phase, Treatment Phase, and Follow-up Phase. 1. Screening Phase You will undergo the following interviews and examinations administered by study physicians: Physicians will collect your medical history and perform physical examinations; blood and urine specimens will be collected for laboratory tests, including routine blood test, blood biochemistry, coagulation function test, routine urinalysis, etc. You will also receive an electrocardiogram (ECG) and B-ultrasound examination of the liver, gallbladder, pancreas, spleen, bilateral kidneys. Study physicians will determine your eligibility for this study based on all above examination results. 2. Treatment Phase After intraoperative bladder emptying, 50 mL of TTP-ICG solution (20 μg/mL) will be instilled into the bladder for a 3-minute full incubation on the entire bladder mucosal surface. Upon completion of incubation, the TTP-ICG solution will be drained, followed by three rounds of bladder irrigation with 50 mL normal saline each time. A dual imaging system integrating white light endoscopy and near-infrared fluorescence endoscopy will then be used to image the whole bladder lining. The number and location of lesions detected under white light and near-infrared fluorescence imaging will be compared and documented, with images and video footage collected for subsequent analysis. All lesions highlighted under near-infrared fluorescence and suspected lesions identified via white light imaging will be resected and sent for pathological examination. 3. Follow-up Phase The follow-up period starts immediately after surgery and lasts until postoperative Day 30. Subjects' vital signs (blood pressure, heart rate, body temperature, etc.) and symptomatic changes will be closely monitored intraoperatively and postoperatively. Blood and urine samples will be collected postoperatively for testing of routine blood, blood biochemistry, coagulation function, routine urinalysis and other indicators, and all adverse reactions experienced by subjects will be recorded.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Age between 18 and 80 years old
* Patients with suspected or confirmed bladder tumor who are scheduled for transurethral partial bladder resection
* Capable of providing written informed consent and adhering to the study protocol

Exclusion Criteria:

* Diagnosis of other invasive malignant tumors
* Severe comorbidities, including congenital malformations, acute inflammatory disease, cachexia, myocardial infarction or cerebrovascular stroke within the previous 6 months, severe liver or renal insufficiency
* Pregnant or breastfeeding female patients
* Patients with gross hematuria or a history of allergic reactions to drugs or food
* Concurrent cystitis, urinary tract malformation or urethral stricture
* Enrollment in another interventional clinical trial within 30 days prior to screening