Optical Biopsy for Thoracic Lymph Nodes.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02689050|
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment|
|Mediastinal Lymphadenopathy Non-small Cell Lung Carcinoma Sarcoidosis||Device: Needle based confocal laser endomicroscopy (nCLE)|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.|
|Actual Study Start Date :||January 13, 2016|
|Actual Primary Completion Date :||March 22, 2017|
|Actual Study Completion Date :||March 22, 2017|
Patients with lymphadenopathy
Patients ≥ 18 years of age, with (suspected) NSCLC or suspected sarcoidosis, and at least one suspected mediastinal/hilar lesion that are scheduled for standard diagnostic endosonographic workup will undergo additional needle based confocal laser endomicroscopy (nCLE) measurements of suspected lesions.
Device: Needle based confocal laser endomicroscopy (nCLE)
During the fine needle aspiration of a suspected and a non-suspected lymph node we will obtain needle based CLE (nCLE) images within the lymph node. Fine needle aspirations will be obtained after the optical biopsy measurements. We will compare the results of the optical biopsy with the cytology results, or to histology in case an additional surgery is indicated.
- The differences on CLE imaging between different disease entities in thoracic lymph nodes (e.g. malignant, reactive and nodes involved in sarcoidosis). [ Time Frame: cross-sectional (2 weeks) ]follow up of 2 weeks after measurements
- Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis. [ Time Frame: cross sectional (2 weeks) ]
- The number of participants with procedure related adverse advents. [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689050
|Academisch Medisch Centrum|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Principal Investigator:||Jouke T Annema, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)|