JMIR Publications

ABSTRACT

Background:

Bladder cancer diagnosis relies on cystoscopy and transurethral bladder tumour resection (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. This study investigates the feasibility of a novel forward-looking micro-electromechanical systems (MEMS)-based OCT catheter to enhance bladder cancer diagnostics.

Objective:

This study primarily aims to assess the feasibility of capturing in vivo cross-sectional images of the bladder wall using a novel MEMS-based OCT catheter. Secondary objectives include evaluating measurement duration, assessing tumor stage and grade from OCT images in comparison to 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 UMC includes patients undergoing TURBT for suspected bladder tumors. Eligible patients must be ≥ 18 years, have at least one cystoscopically accessible tumor and must be physically fit for TURBT. Exclusion criteria include pregnancy, tumors >2 cm, >5 tumors, isolated flat lesions, or tumors solely at the bladder neck. Primary endpoints assess the procedural feasibility of OCT imaging, while secondary endpoints evaluate tumor staging, grading, and correlation with histopathology. Up to 25 patients will be enrolled, with feasibility achieved if diagnostic images are obtained in >60% of cases. OCT imaging is performed before and after tumor resection, with histopathological results used for comparison. Patients will be monitored for adverse events for four weeks post-procedure, after which study participation ends.

Results:

As of December 2024, three participants have been enrolled. The projected end date of the study is November 2025 and results are expected to be published in March 2026.

Conclusions:

This study will establish the feasibility of using the MEMS-based OCT catheter and system for in vivo bladder imaging, laying the groundwork for a larger trial to evaluate its diagnostic accuracy in staging and grading bladder cancer. Clinical Trial: NCT06679920, clinicaltrials.gov.