AI-enhanced blue light cystoscopy for bladder cancer detection
Official title: Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Run by Photocure · NCT07144319 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Photocure Industry-sponsored |
| Locations | 12 sites (Tampa, Florida and 11 other locations) |
| Status | Recruiting |
| Started | March 25, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07144319 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
University of Iowa Health Care
Iowa City, Iowa, United States Recruiting -
Regents of the University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Rutgers Cancer Institute
New Brunswick, New Jersey, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting -
UZ Leuven
Leuven, Belgium Recruiting
Show 6 more locations
-
Vancouver Prostate Centre at Vancouver General Hospital
Vancouver, Canada Recruiting -
Department of Urology, University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, Germany Recruiting -
Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum
Herne, Germany Recruiting -
Klinik und Poliklinik für Urologie, TUM Klinikum
München, Germany Recruiting -
Universitätsklinikum Ulm, Klinik für Urologie und Kinderurologie
Ulm, Germany Recruiting -
Oslo University Hospital
Oslo, Norway Recruiting
Study contacts
- Study coordinator: Kristine Young-Halvorsen, PhD
- Email: research@photocure.com
- Phone: 004722062210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing CT and MRI with VI-RADS for Bladder Cancer Staging
This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.
-
Tracking quality of life and relapses in bladder cancer patients after surgery
This study is tracking how bladder cancer patients feel and whether their cancer comes back after surgery over the next 10 years.
-
Mindfulness and exercise program for bladder cancer surgery patients
This study is testing a home program that combines exercise and mindfulness to help bladder cancer patients feel better and prepare for their surgery.
-
Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy
This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.
-
Urinary Cell-Free DNA Test for Urothelial Cancer Origin
This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.
-
BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy
This trial tests whether T-bren can help people with HER2-expressing metastatic urothelial cancer who progressed after anti-PD-(L)1 therapy, compared with standard platinum-based chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.