In-vivo focal prostate imaging with confocal laser endomicroscopy and optical coherence tomography

Phase 2

Completed

• Conditions: carcinoma of the prostate; prostate cancer; 10036958

• Registration Number: NL-OMON47550
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

For procedure 1: planned for TTMB
For procedure 2: Localized prostate cancer visible on MRI

Exclusion Criteria

Patients with a known allergic reaction to fluorescein

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Procedure 1 primary parameters/endpoints:<br /><br>- Technical feasibility of CLE and OCT in the prostate by transperineal approach<br /><br><br /><br>Procedure 2 primary parameters/endpoints:<br /><br>- In-vivo images made with CLE and OCT of the different tissues in the<br /><br>prostate, verified by histopathology</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Procedure 1 secondary parameters/endpoints:<br /><br>- List of procedure-related adverse events of needle based OCT and CLE<br /><br><br /><br>Procedure 2 secondary parameters/endpoints:<br /><br>- Technical feasibility of CLE and OCT in the prostate by transperineal approach<br /><br>- List of procedure-related adverse events of needle based OCT and CLE<br /><br>- Visual descriptive image criteria for CLE and OCT images of the different<br /><br>prostate tissues</p><br>