Optical coherence tomography: Measurement with opctical coherence tomography of tumour and normal bladder tissue during transurethral resection of a bladder tumour (TURBT)
Study summary
The goal of this clinical trial is to see if a new designed optical coherence tomography catheter can be used in bladder cancer in patients undergoing a transurethral resection of a bladder tumour. The main question it aims to answer is:
\- Is the optical coherence tomography catheter feasible in capturing images of bladder tumours and normal bladder wall during a transurethral resection of a bladder tumour?
Participants will undergo measurements with a new optical coherence tomography device during the transurethral resection of their bladder tumour(s).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age \> 18 years.
* Have at least 1 suspected bladder tumour seen at cystoscopy.
* Have a bladder that is accessible for cystoscopy.
* Be in a physical condition to undergo a TURBT.
* Eligible patients must be fully informed about the study and written signed informed consent must be obtained prior to any study related investigation/intervention.
Exclusion Criteria:
* Pregnant or lactating women.
* The only tumour site is at the bladder neck.
* The tumour(s) is larger than 2 centimetres in diameter.
* \>5 tumours present.
* Solely a suspected flat lesion present.
Primary outcome measure(s)
Procedural feasibility — During the TURBT The ability to generate images of the normal bladder wall and bladder tumour(s). Feasibility will be achieved if diagnostic images of the tumour and normal bladder are obtained in over 60% of the patients.
Image utilization feasibility — During the TURBT Feasibility will also be assessed by determining the percentage of images suitable for diagnosis out of the total number obtained. A percentage exceeding 80% will be deemed feasible.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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