Confocal Laser Endomicroscopy before transurethral resection for optimizing Bladder Cancer diagnosis and treatment.

Recruiting

• Conditions: bladder cancer; urothelial carcinoma of the bladder; 10038364; 10004994

• Registration Number: NL-OMON55286
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- papillary bladder cancer
- 18 years or older
- bladder that is accessible transurethral for cystoscopic follow up.

Exclusion Criteria

- allergy for fluorescein

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Overall accuracy, sensitivity and specificity of flexible probe CLE-based<br /><br>diagnosis (benign vs malignant) and grading (low-grade versus high-grade) in<br /><br>comparison with the histopathology of the resection specimen.<br /><br>2. Overall accuracy, sensitivity and specificity of CLE-based assessment of the<br /><br>surgical radicality of the resection bed (radical versus irradical) in<br /><br>comparison with the histopathology of the biopsy of the resection bed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Diagnostic accuracy of computer aided diagnosis based on CLE images compared<br /><br>to histopathology. </p><br>