Feasibility of confocal laser endomicroscopy in bladder cancer digsnosis

Cystoscopy and cytology, the current *gold standard* for detection and
follow-up of primary and recurrent bladder cancer have some limitations. CLE, a
high resolution imaging technique, that can be used combined with
endo-urological procedures, seems promising to improve diagnosis of bladder
cancer. The diagnostic accuracy of cystoscopic applied CLE still has to be
defined.

To directly correlate CLE images with histopathology, and identify and define
CLE characteristics of normal urothelium, benign bladder urothelium, and
bladder tumors (low-grade, high-grade NMIBC or CIS) of the lower urinary tract.

This is a prospective, multicenter, observational study. Diagnostic accuracy of
CLE will be established by comparing CLE diagnosis with pathological diagnosis,
the reference standard.

A participating patient will not benefit from this study. However, the results
of this study may benefit the diagnostic procedure for bladder tumors in the
future. There is little burden related to study participation. During TURB
(standard procedure), before tumor resection the CLE probe will be held in
direct contact with the bladder tumor to obtain CLE images. Before image
acquisition we administer fluorescein, which is a commonly used fluorescent
dye. In patients not at risk for a demonstrated allergic reaction to this dye
this is safe. Patients with a known allergic reaction to fluorescein cannot
participate in this study. Aside from tumor resection, a small chip of normal
urothelium will be resected. This will act as a control and is included in the
CLE atlas. The risks for resecting this extra chip of tissue are minimal.
The estimated prolonged time per-operatively is approximately 15 minutes.
Adverse events are not expected. Standard care and pathological evaluation as
stated by the hospitals* internal protocol will not be affected by this study.
In conclusion, we believe that the burden and risk associated with
participation in this study are low.