Trial intelligence / Profile preview

Trop2-Targeted NIR Fluorescence Imaging for NMIBC Resection

NCT07800507Phase 2

Key facts

Status
Not yet recruiting
Start
Oct 2026
Primary completion
Jul 2027
Countries
1
Sponsor
Yunnan Cancer Hospital
Drugs
TTP-ICG
Conditions
non-muscle-invasive bladder cancer (NMIBC)
01

Overview

Phase 2, open-label, single-arm trial of TTP-ICG in non-muscle-invasive bladder cancer (NMIBC), sponsored by Yunnan Cancer Hospital. Primary endpoints: Number of participants with treatment-related adverse events at 1 year, Number of participants with clinically significant abnormal laboratory test results at 1 year and 5 more. Planned start Oct 2026; status: not yet recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Trop2-Targeted NIR Fluorescence Imaging-Guided Precise Resection of NMIBC

    All enrolled subjects receive TTP-ICG intravesically prior to imaging and resection.

03

Who it enrols

Adult patients with suspected or confirmed bladder tumor scheduled for transurethral partial bladder resection, excluding those with other invasive malignancies, severe comorbidities, or pregnancy.

04

Endpoints

Primary

  • Number of participants with treatment-related adverse events

  • Number of participants with clinically significant abnormal laboratory test results

  • Changes in baseline vital signs

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

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

Secondary

  • Intraoperative NIR mean fluorescence intensity

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