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Study With a Newly Optical Coherence Tomography Probe for Optimizing Bladder Cancer Diagnosis and Treatment

ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Optical coherence tomography

    Device

    Measurement with opctical coherence tomography of tumour and normal bladder tissue during transurethral resection of a bladder tumour (TURBT)

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Optical coherence tomography measurements during transurethral resection of a bladder tumourOther 1 intervention

Trial outcomes

Primary outcomes

1

Procedural feasibility

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.

Time frame
During the TURBT
2

Image utilization feasibility

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.

Time frame
During the TURBT

Secondary outcomes

1

Duration of the measurements

The duration of the OCT measurements in minutes

Time frame
During the TURBT
2

Concordance tumour stage based on OCT with histopathology

The overall concordance between the OCT catheter diagnosis of tumour invasion (stage) compared with the pathological results of the resected tissue(s)

Time frame
From TURBT to histopathology result (approximately 4 weeks)
3

Concordance between tumour grade based on OCT and histopathology

The overall concordance between the OCT catheter diagnosis of tumour grade compared with the pathological results of the resected tissue(s).

Time frame
From TURBT to histopathology result (approximately 4 weeks)
4

Evaluable resection bed OCT images

The ability of the OCT catheter to acquire evaluable images of the resection bed.

Time frame
During the TURBT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

Source ClinicalTrials.gov
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