Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy

Part of paid clinical trials in Tampa, Florida.

Sponsor
Photocure
Study ID
NCT07144319
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Mar 25, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: BLC patients
    Adult, consenting patients scheduled for BLC as part of clinical practice.

Primary Outcome Measure

Video and image collection [ Time Frame: 1 day ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Roger Li, MD
[email protected]
813-745-8343
Regents of the University of MichiganAnn ArborMichigan48108
Todd Morgen, MD
[email protected]
734-936-1902
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Vignesh Packiam, MD
[email protected]
732-235-2465

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Moffitt Cancer Center· Tampa, FLRegents of the University of Michigan· Ann Arbor, MIRutgers Cancer Institute· New Brunswick, NJ

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