Actively Recruiting

Age: 18Years +
All Genders
ID05415631

Augmented Bladder Tumor Detection Using the Bladder-Portable Artifact Detection System: A Multicentric Prospective Analytic Study Using Real Time Based Artificial Intelligence

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2022-07-15

500

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new method to improve the diagnosis and monitoring of bladder tumors by combining traditional bladder endoscopy with an artificial intelligence (AI) based diagnostic tool called the Bladder-Portable Artifact Detection System (Bladder-PAD). The study aims to reduce diagnostic errors and standardize tumor descriptions to better characterize tumor aggressiveness and improve patient care. This observational study is led by the Centre Hospitalier Universitaire, Amiens. The study uses video frames extracted from a dataset of cystoscopy videos, which are then analyzed using a pre-trained convolutional neural network model with feature detection algorithms. The Bladder-PAD system will be assessed for its ability to detect bladder tumors and predict the risk of tumor recurrence and progression compared to standard white light cystoscopy. Participants will undergo cystoscopy examinations where tumor detection rates and false detection rates will be measured for both white light cystoscopy and Bladder-PAD cystoscopy on the same day. Data analysis will occur at both patient and lesion levels to evaluate the accuracy of the AI system. The study involves no treatment intervention but focuses on diagnostic performance, aiming to develop a precise diagnostic companion tool for bladder tumor management.

CONDITIONS

Brief Title

Augmented Bladder Tumor Detection Using Real Time Based Artificial Intelligence

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unifocal primary or recurrent suspected bladder cancer with tumor size less or equal than 3 cm
  • Multifocal primary or recurrent suspected bladder cancer with 5 or fewer lesions and each tumor size less or equal than 3 cm
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • More than 5 tumors or any tumor larger than 3 cm
  • Suspected muscle-invasive bladder cancer (cT2 or higher) based on computed tomography or cystoscopy
  • Evidence of distant metastases on computed tomography or magnetic resonance imaging
  • Gross hematuria
  • Bacillus Calmette-Guerin (BCG) treatment or chemotherapy within 3 months prior to inclusion, except a single course immediately following TUR
  • Patients who do not consent to the use of their data for research

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo cystoscopy procedures using white light and Bladder-PAD cystoscopy to detect bladder tumors.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Amiens University Hospital

Amiens, France, 80054

Actively Recruiting

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Research Team

F

Fabien SAINT, Pr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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