Fluorescent bladder imaging to help find non-muscle invasive bladder cancer during surgery
Tests a glowing dye to spot bladder cancer lesions during surgery in adults.
Plain-language title generated from the registry record
Registry title: Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer
Key facts
- Where
- Kunming, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07800507, who can take part
Where in China
- Yunnan Cancer HospitalKunming, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yunnan Cancer Hospital
- Trial code
- NCT07800507
- Record updated
- 24 September 2026
- Original description
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).Read full original descriptionShow less
Study on Precise Resection of Non-Muscle Invasive Bladder Cancer Guided by Trop2-Targeted Near-Infrared Fluorescence Imaging Technology
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.
Inclusion: 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: Severe comorbidities, including congenital malformations, acute inflammatory disease, cachexia, myocardial infarction or cerebrovascular stroke within the previous 6 months, severe liver or renal insufficiency; Concurrent cystitis, urinary tract malformation or urethral stricture; Enrollment in another interventional clinical trial within 30 days prior to screening; Diagnosis of other invasive malignant tumors; Patients with gross hematuria or a history of allergic reactions to drugs or food; Pregnant or breastfeeding female patients.