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CLE in diagnosing pleural malignancies, a comparison with pathology

CLE in diagnosing pleural malignancies, a comparison with pathology - CLE for diagnosing pleural malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45606
Enrollment
20
Registered
2017-03-22
Start date
2017-08-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mesothelioom Pleural thickening

Interventions

mesothelioma
pleural malignancies

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
- To describe and develop visual descriptive image criteria for CLE images of malignant, normal and fibrotic areas (thoracic wall, pleura, mediastinum) - To obtain quantitative measures by CLE imaging of these malignancies

Secondary

MeasureTime frame
- Assessing technical feasibility of CLE by several approaches used in the process of diagnosis or staging (% of successful videos/time for procedure (min)) - Assessing procedure-related adverse events of CLE in this group of patients

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)