Sarcoidosis Clinical Trial
Official title:
Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.
Verified date | September 2017 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
EUS-FNA is the recommended diagnostic examination of choice when patients present with suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in costs, and although it has a good record in detecting diseases (eg confirm a nodal metastasis or granulomas) it has limitations in excluding diseases (missing metastases/ or granulomas) resulting in a false negative rate of 15-20%. Substantial limitations that most likely can be attributed to areas within the node that are not sampled during EUS-FNA tissue acquisition. Improved needle based EBUS/ EUS guided nodal diagnostics might result in improved quality of the fine needle aspirations, reduce in surgical diagnostic procedures , reduced costs and result in a shorter timebefore-treatment interval.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 22, 2017 |
Est. primary completion date | March 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - =18 years of age - Suspected or tissue proven sarcoidosis (stage I or II based on CT/PET-CT) and referred for diagnostic endosonographic work up or - Suspected or tissue proven NSCLC with suspected mediastinal lymph nodes within reach of EUS-FNA Exclusion Criteria: - Inability and willingness to provide informed consent - Inability to comply with the study protocol - Patients with known allergy for fluorescein - use of betablokker within 24 hours before procedure - possible pregnancy or lactating women |
Country | Name | City | State |
---|---|---|---|
Netherlands | Academisch Medisch Centrum | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The differences on CLE imaging between different disease entities in thoracic lymph nodes (e.g. malignant, reactive and nodes involved in sarcoidosis). | follow up of 2 weeks after measurements | cross-sectional (2 weeks) | |
Secondary | Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis. | cross sectional (2 weeks) | ||
Secondary | The number of participants with procedure related adverse advents. | 2 weeks |
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