AI-enhanced blue light cystoscopy for bladder cancer detection
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Photocure · NCT07144319
This project will collect blue light cystoscopy videos from adults having Hexvix/Cysview-enhanced cystoscopy and test AI tools to help doctors better find bladder cancer during the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Photocure (industry) |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT07144319 on ClinicalTrials.gov |
What this trial studies
This is an observational data collection effort that records blue light cystoscopy video from adults who receive Hexvix/Cysview prior to their procedure, with biopsies taken when clinically indicated and video-confirmed. The recorded videos will be linked to clinical and pathology findings where available to create a high-quality, diverse dataset. The dataset is intended to support development of computer-aided detection (CADe) tools to reduce operator variability in visual assessment of the bladder surface. The work is being carried out at participating tertiary centers in the United States and Norway.
Who should consider this trial
Good fit: Adults aged 18 or older who provide informed consent and are already scheduled to undergo Hexvix/Cysview-enhanced blue light cystoscopy with potential biopsies are ideal candidates.
Not a fit: Patients who are not having blue light cystoscopy, are under 18, or who do not consent will not benefit from participation in this data collection.
Why it matters
Potential benefit: If successful, AI tools trained on this dataset could help doctors detect more tumors, reduce missed lesions, and make cystoscopy interpretation more consistent.
How similar studies have performed: Blue light cystoscopy is already known to improve tumor detection and early pilot studies of AI-assisted cystoscopy have shown promise, but larger, diverse datasets are still needed to validate AI approaches clinically.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Written informed consent, approved by relevant IRB/IEC, signed * Hexvix/Cysview has been prescribed in the usual manner in accordance with the terms of the marketing authorization (see Appendix B) * Physician has planned to do a blue light cystoscopy on the patient and to obtain biopsies, if clinically indicated, of suspicious lesions with video confirmation. * Patient has not previously taken part in this study Exclusion Criteria: * None
Where this trial is running
New Brunswick, New Jersey and 1 other locations
- Rutgers Cancer Institute — New Brunswick, New Jersey, United States (RECRUITING)
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Study coordinator: Kristine Young-Halvorsen, PhD
- Email: research@photocure.com
- Phone: 004722062210
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.
Conditions: Bladder Cancer, Non-muscle Invasive Bladder Cancer, bladder cancer, artificial intelligence, cystoscopy