Using a new imaging technique to improve 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
This study is testing a new imaging tool to see if it can help doctors better diagnose and treat bladder cancer during surgery, making things easier for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam, North Holland and 1 other locations) |
| Trial ID | NCT06679920 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility of a newly designed optical coherence tomography (OCT) catheter for capturing images of bladder tumors and the normal bladder wall during transurethral resection of bladder tumors (TURBT). By utilizing OCT, the study seeks to provide a non-invasive 'optical biopsy' method that could potentially reduce the need for repeat TURBT procedures and improve the grading and staging of bladder cancer. Participants will undergo imaging with the OCT device during their TURBT procedure, which may lead to better treatment options and reduced healthcare costs for bladder cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with at least one suspected bladder tumor identified during cystoscopy.
Not a fit: Patients who are pregnant, have tumors larger than 2 centimeters, or have multiple tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate bladder cancer diagnoses and potentially reduce the frequency of invasive procedures for patients.
How similar studies have performed: Previous studies have shown promising results with optical coherence tomography in the upper urogenital tract, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Amsterdam, North Holland and 1 other locations
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Not_yet_recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marinka Remmelink, MD
- Email: m.j.remmelink@amsterdamumc.nl
- Phone: +310204441376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.