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Clinical Trials in Belgium / NCT07144319
Recruiting Observational

Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy

NCT07144319 · tracked via the Priya Life Science Belgium tracker
Sponsor
Photocure
Phase
Observational
Started
2026-03-25
Last updated
2026-09-04

Condition(s) studied

Bladder CancerNon-muscle Invasive Bladder Cancer

Study summary

Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions. Unlike regular white light cystoscopy, blue light cystoscopy makes use of a drug that induces fluorescence under blue light preferentially in neoplastic and malignant cells that helps visualize bladder lesions during the cystoscopic procedure. Blue light cystoscopy has shown to improve detection of bladder cancer.

Cystoscopy, including blue light cystoscopy, is a procedure involving assessment of the visual appearance of the bladder surface, leading to decisions of taking biopsies, remove suspicious areas and assign treatment options. The assessment is subjective and has a large operator variability. These shortcomings show an opportunity for computer aided detection (CADe) medical device to add value to both clinicians and patients.

The objective of this data collection study is to build a high-quality, diverse data set of video, image recordings and relevant clinical data from BLC procedures performed as part of routine clinical practice to train a computer-aided detection (CADe) algorithm for real- time lesion detection during cystoscopy. The data will be used to support the training, non-clinical technical development and testing of such AI algorithms for use during cystoscopy and to provide documentation needed for training of such algorithms and to assist in guiding future validation of such algorithms.

Exploratory purposes of the study is to use data to explore future AI algorithms in bladder cancer, such as computer-aided diagnosis (CADx) AI algorithms, image enhancement and cystoscopy improvement algorithms, including bladder mapping, tumor visualization, cystoscopy documentation, and combination models of image and clinical data including risk assessment, clinical outcomes, and disease modeling

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Moffitt Cancer Center Tampa Florida Recruiting
Regents of the University of Michigan Ann Arbor Michigan Recruiting
Rutgers Cancer Institute New Brunswick New Jersey Recruiting
UZ Leuven Leuven Belgium Recruiting
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 Not Yet Recruiting
Oslo University Hospital Oslo Norway Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07144319 on ClinicalTrials.gov ↗ ← All trials in Belgium