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

NCT07800507 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: KYLX2026-035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Screening Phase
2. 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.
3. 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

Keywords

NMIBC; Bladder Cancer(BC); Trop2; NIR

Outcome Measures

Primary Outcomes (7)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• 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

  1 year

• Specificity of near-infrared fluorescence imaging for tumor lesion detection

  Calculate diagnostic specificity of TTP-ICG mediated near-infrared fluorescence imaging for identifying pathological tumor lesions confirmed by postoperative pathological gold standard. Unit of Measure: Percentage

  1 year

• False positive rate of near-infrared fluorescence imaging for tumor lesion detection

  Calculate false positive rate of TTP-ICG mediated near-infrared fluorescence imaging for identifying pathological tumor lesions confirmed by postoperative pathological gold standard. Unit of Measure: Percentage

  1 year

• False negative rate of near-infrared fluorescence imaging for tumor lesion detection

  Calculate false negative rate of TTP-ICG mediated near-infrared fluorescence imaging for identifying pathological tumor lesions confirmed by postoperative pathological gold standard. Unit of Measure: Percentage

  1 year

Secondary Outcomes (1)

• Intraoperative NIR mean fluorescence intensity (MFI) of bladder tumor lesions and normal bladder mucosal epithelium

  1 year

Study Arms (1)

Trop2-Targeted NIR Fluorescence Imaging-Guided Precise Resection of NMIBC

EXPERIMENTAL

All enrolled subjects will be assigned to this arm.

Drug: TTP-ICG NIR fluorescent diagnostic agent

Interventions

TTP-ICG NIR fluorescent diagnostic agent DRUG

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.

Trop2-Targeted NIR Fluorescence Imaging-Guided Precise Resection of NMIBC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead
• Xiamen University: collaborator

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Shengjie Lin, Doctor of Medicine

CONTACT

86+18359010705; linshengjie1128@163.com

Jingwen Bai, Doctor of Medicine

CONTACT

86+13411961052; baijingwen666@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: September 2, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-07

Locations

CN (1)