IDEAL Phase II Study of a Newly Designed Optical Coherence Tomography Probe During Transurethral Resection for Optimizing Bladder Cancer Diagnosis and Treatment

Rationale:

Bladder cancer is the 10th most common form of cancer in the world with 573.278 new cases of bladder cancer and 212,536 deaths in 2020. Despite current treatment options, 5-year recurrence rates up to 78% have been reported. Therefore, frequent and long-term follow-up of bladder cancer patients is required. Up until now, the gold standard for diagnosing bladder cancer is cystoscopy with subsequent transurethral resection of the bladder tumour (TURBT). In certain cases a repeat-TURBT (re-TURBT) is necessary to ensure radicality and to confirm the stage of the tumour. The frequent cystoscopies and multiple operations result in a substantial burden for bladder cancer patients and in substantial healthcare costs. Therefore, finding other options to determine the tumour grading and staging by a so called 'optical biopsy' is necessary. This would enable other treatment options, such as out-patient laser fulguration or active surveillance reducing the subsequent TURBT after cystoscopy.

Optical coherence tomography (OCT) is an optical technique that uses infrared light to create high resolution, real-live images of tissue. OCT has been studied in the upper urogenital tract for urothelial carcinoma with good results. However, this is a different situation, since the ureter is a tubular structure with limited space and the tested OCT probe is a sideward looking probe. Previously, two different, forward looking, OCT probes have been studied in the bladder. The studies show different results on sensitivity and specificity. Some results are very promising, while others show no advantage for OCT over white light cystoscopy (WLC). However, the studied probes have a low frames per second (FPS) rate. This results in stammering images and makes the probes very sensitive for motion artefacts. Furthermore, both OCT catheters are not on the market (anymore). Since the OCT techniques have improved over the last decade, a new forward looking OCT probe has been developed. The newly designed OCT catheter has a much higher FPS rate and has used techniques to improve the resolution of the images. Therefore, the newly designed micro-electro-mechanical system (MEMS) based OCT catheter looks promising to improve the diagnosis and treatment of bladder cancer. The present study is an IDEAL stage-IIa feasibility study.

Objectives:

The primary objective: