IDEAL phase IIa study of a newly designed Optical Coherence Tomography probe during transurethral resection for optimizing bladder cancer diagnosis and treatment

Bladder cancer is the 10th most common form of cancer in the world with 549.000
new cases of bladder cancer and 200.000 deaths in 2018. 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 OCT
catheter looks promising to improve the diagnosis and treatment of bladder
cancer. The present study is a phase-I feasibility study.

The primary objective:
- To investigate the feasibility of capturing in-vivo cross section images of
the bladder wall in bladder cancer patients with the OCT catheter.

Secondary objectives:
- To evaluate the duration of the OCT measurements.
- To determine the depth of invasion of the tumour on the OCT images and
correlate this to the histopathological results of the resected tissue(s).
- To determine the grade of the tumour from the OCT images and correlate this
to the histopathological results of the resected tissue(s).
- To determine if the OCT catheter is able to acquire assessable images of
resection beds.
- To compare the tumour grade and invasion estimated by the urologist during
WLC with the tumour grade and invasion determined by the OCT images.

A prosepective, mono-center, IDEAL phase IIa clinical study to investigate the
feasibility of the newly designed OCT catheter.

There is little burden for the patients. The only burden is a prolonged
operation time which is expected to be approximately 20 minutes. There is no
additional risk for the patient, since the OCT catheter is inserted through the
working channel of the resectoscope that is used for the TURBT. There is no
benefit for participants of this study. The burden and risks of this study are
the same for all participants. The patients will receive the standard of
clinical care during participation and the histopathological evaluation will
not be affected by the study protocol.