Bladder cancer bladder carcinoma
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The procedural feasibility of the OCT measurement, assessed by the ability to create an image of the normal bladder wall and of the bladder tumour(s), as judged by the operating urologist. A percentage of >60% will be considered as feasible. This has to be reached in 15 procedures limiting the inclusion to a maximum of 25 patients. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The duration of the OCT measurements in minutes. - The overall accordance between the OCT catheter diagnosis of tumour invasion (stage) compared with the pathological results of the resected tissue(s). - The overall accordance between the OCT catheter diagnosis of tumour grade compared with the pathological results of the resected tissue(s). - The ability of the OCT catheter to acquire assessable images of the resection bed. - The accordance between tumour grade and invasion estimated by the urologist during WLC and the tumour grade and invasion determined by the OCT images and histopathology. | — |
Countries
Netherlands
Outcome results
None listed