Actively Recruiting
Trop2-targeting Near-Infrared II Fluorescence Molecular Probe for Guided Identification of Non-Muscle-Invasive Bladder Cancer
Led by Yunnan Cancer Hospital · Updated on 2025-05-30
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bladder cancer is a common malignancy, especially among men in the United States, with most patients presenting with non-muscle-invasive bladder cancer (NMIBC). Current diagnosis and treatment methods, including white light cystoscopy and transurethral resection of bladder tumors, have a high recurrence rate and can miss some tumors. Researchers are evaluating a novel near-infrared fluorescence imaging probe, called TTP-ICG, which targets Trop2 to help distinguish cancerous tissue from non-cancerous tissue during surgery. The study involves soaking excised bladder tissues in solutions with different concentrations of TTP-ICG for varying times, followed by rinsing and drying. Using a specialized imaging system, researchers will capture fluorescence images to analyze how well the probe highlights cancer tissues compared to surrounding tissues. Additional tests will include staining and immunohistochemistry to confirm the imaging results. Participants will undergo surgery as planned, and their removed tissues will be processed with the TTP-ICG probe. Researchers will assess the ability of this method to differentiate cancer from non-cancer tissue and compare imaging results with pathological diagnoses. The primary outcome is to measure differentiation between bladder cancer and adjacent tissue within six months. Safety and study participation will be monitored throughout, with study completion expected by late 2025.
CONDITIONS
Brief Title
Trop2-targeting NIR-II Molecular Probe for Guided Identification of Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients unable to participate in the consent process
- Patients with contraindications to surgery, such as serious cardiopulmonary disease or coagulation dysfunction
- Other conditions that the researcher considers inappropriate to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgical treatment based on clinical diagnosis and treatment.
1 visit (in-person)
Duration - Same day as surgery
Excised tissues are incubated with TTP-ICG solution at varying concentrations and times, rinsed, dried, and then imaged using the NIR-II fluorescence system.
No additional visits; procedures performed on excised tissues
Duration - Up to 6 months
Analysis of pathological diagnosis and correlation with fluorescent imaging data is conducted over time to differentiate bladder cancer tissues.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
Research Team
S
Shengjie Lin, Doctor of Medicine
J
Jingwen Bai, Doctor of Medicine
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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