CLE in diagnosing pleural malignancies, a comparison with pathology

Completed

• Conditions: mesothelioom; Pleural thickening; 10027412; 10035597

• Registration Number: NL-OMON45606
• 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: 20

Inclusion Criteria

-*18 years of age
-Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, transthoracic biopsy or endosonography.

Exclusion Criteria

-Inability and willingness to provide informed consent
- Inability to comply with the study protocol
- Patients with known allergy for fluorescein or risk factors for an allergic reaction:
- use of betablokker within 12 hours before start of the procedur
- possible pregnancy or lactating women

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- To describe and develop visual descriptive image criteria for CLE images of<br /><br>malignant, normal and fibrotic areas (thoracic wall, pleura, mediastinum)<br /><br>- To obtain quantitative measures by CLE imaging of these malignancies </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessing technical feasibility of CLE by several approaches used in the<br /><br>process of diagnosis or staging (% of successful videos/time for procedure<br /><br>(min))<br /><br>- Assessing procedure-related adverse events of CLE in this group of patients</p><br>