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.
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
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
Single group
TTP-ICG NIR fluorescent diagnostic agent
DrugAfter intraoperative bladder emptying, 50 mL of TTP-ICG solution (20 μg/mL) will be instilled into the bladder for a 3-minute full incubation over the entire bladder mucosal surface. Upon incubation completion, the TTP-ICG solution will be drained, followed by three cycles of bladder irrigation with 50 mL normal saline per cycle, with each irrigation lasting 30 seconds. A dual-modal white-light and near-infrared fluorescence endoscopic imaging system will then be utilized to image the whole bladder lumen. The number and anatomical location of lesions detected under white light and NIR fluorescence will be recorded and compared; images and video recordings will be archived for subsequent analysis. All lesions highlighted under NIR fluorescence and suspected lesions identified under white light endoscopy will be resected and submitted for pathological examination.
Number of participants with treatment-related adverse events graded per CTCAE v4.0
Count the number of subjects who develop adverse events causally related to TTP-ICG administration, categorized by adverse event severity grade defined by CTCAE v4.0. The primary aggregated outcome is the count of affected participants.
Number of participants with clinically significant abnormal laboratory test results
Summarize participants presenting with clinically meaningful abnormal blood routine, biochemistry, coagulation and urine laboratory indicators after TTP-ICG administration, aggregate to the total number of participants with abnormal laboratory findings.
Changes in baseline vital signs (aggregated abnormal vital sign occurrence count)
Collect heart rate, systolic/diastolic blood pressure, body temperature, respiratory rate at baseline and post-administration timepoints. Aggregate data to calculate the number of participants with vital signs deviating from normal clinical reference ranges.
Sensitivity of near-infrared fluorescence imaging for tumor lesion detection
Calculate diagnostic sensitivity of TTP-ICG mediated near-infrared fluorescence imaging for identifying pathological tumor lesions confirmed by postoperative pathological gold standard. Unit of Measure: Percentage
Intraoperative NIR mean fluorescence intensity (MFI) of bladder tumor lesions and normal bladder mucosal epithelium
Intraoperative NIR fluorescence images are acquired with a 4K high-definition fluorescent laparoscopic system. ImageJ software is used for quantitative fluorescence analysis. Regions of interest (ROIs) are delineated on monochromatic NIR images covering tumor lesions and normal bladder mucosal epithelium, followed by quantification of the mean fluorescence intensity (MFI) for each ROI. Unit of Measure: Arbitrary fluorescence unit
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Yunnan Cancer Hospital
Lead sponsor
Xiamen University
Collaborator
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