Newly Designed Optical Coherence Tomography Catheter for Optimizing Bladder Cancer Diagnosis and Treatment: Protocol for a Feasibility Study

BACKGROUND: Bladder cancer diagnosis relies on cystoscopy and transurethral resection of bladder tumor (TURBT) for histopathological evaluation, but this process is time consuming, costly, and subject to variability. Optical coherence tomography (OCT) offers real-time, high-resolution imaging as a potential alternative. OBJECTIVE: This study primarily aims to assess the feasibility of capturing in vivo cross-sectional images of the bladder wall using a novel microelectromechanical systems (MEMS)-based OCT catheter. Secondary objectives include evaluating measurement duration, assessing tumor stage and grade from OCT images in comparison with histopathology, determining the catheter's ability to image resection beds, and comparing OCT-based tumor staging with white light cystoscopy assessments. METHODS: This single-center feasibility study at Amsterdam University Medical Center includes patients undergoing TURBT for suspected bladder tumors. Eligible patients must be aged 18 years or older, have at least 1 cystoscopically accessible tumor, and must be physically fit for TURBT. Exclusion criteria include pregnancy, tumors larger than 2 cm, more than 5 tumors, isolated flat lesions, or tumors solely at the bladder neck. The primary end point assesses the procedural feasibility of OCT imaging, while the secondary end points evaluate tumor staging, grading, and correlation with histopathology. Up to 25 patients will be enrolled, with feasibility achieved if diagnostic images are obtained in more than 60% of the cases. OCT imaging is performed before and after tumor resection, with histopathological results used for comparison. Patients will be monitored for adverse events for 4 weeks after the procedure, after which study participation ends. RESULTS: As of November 2025, 16 participants have been enrolled, and 13 have successfully completed the study procedure. The projected end date of the study is November 2025, and results are expected to be published in March 2026. CONCLUSIONS: This study is expected to provide key insights into the feasibility and clinical utility of the newly developed MEMS-based forward-looking OCT system for real-time bladder imaging during TURBT. This study will lay the groundwork for a larger trial to evaluate its diagnostic accuracy in staging and grading bladder cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT06679920; https://clinicaltrials.gov/study/NCT06679920. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/76644.

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