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

Summary

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.

Conditions

• NMIBC

Interventions

DRUG

TTP-ICG NIR fluorescent diagnostic agent

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 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.

Sponsors & Collaborators

• Xiamen University

  collaborator OTHER

• Yunnan Cancer Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-08

Primary Completion

2027-05-30

Completion

2027-06-30

Countries

• China

Study Locations