Clinical trial · Interventional
Study With a Newly Optical Coherence Tomography Probe for Optimizing Bladder Cancer Diagnosis and Treatment
IDEAL Phase II Study of a Newly Designed Optical Coherence Tomography Probe During Transurethral Resection for Optimizing Bladder Cancer Diagnosis and Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optical coherence tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Optical coherence tomography measurements during transurethral resection of a bladder tumour
- description
- Single arm
- interventionNames
- Device: Optical coherence tomography
Primary outcomes (2)
- measure
- Procedural feasibility
- timeFrame
- During the TURBT
- description
- 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.
- measure
- Image utilization feasibility
- timeFrame
- During the TURBT
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRemmelink MJ, Nieuwenhuijzen JA, de Bruin DM, Oddens JR. Newly Designed Optical Coherence Tomography Catheter for Optimizing Bladder Cancer Diagnosis and Treatment: Protocol for a Feasibility Study. JMIR Res Protoc. 2025 Dec 2;14:e76644. doi: 10.2196/76644. PMID 41329952