NCT02689050

Optical Biopsy for Thoracic Lymph Nodes.

Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Needle based confocal laser endomicroscopy (nCLE) is a modern imaging technique, compatible with the conventional diagnostic aspiration needle, that uses an excitation laser light to create 'real-time' microscopic images of tissues. Therefore this technique provides additional information regarding the nodal status and could therefore improve the diagnostic yield of EUS-FNA. Specifically, we will describe the nCLE image characteristics of lymph nodes involved in lung cancer and sarcoidosis as well as in healthy lymph nodes. Improved characterization of mediastinal nodes might lead to improved diagnosis.

Conditions

• Mediastinal Lymphadenopathy
• Non-small Cell Lung Carcinoma
• Sarcoidosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-13
• Primary completion: 2017-03-22
• Completion: 2017-03-22
• First posted: 2016-02-23
• Last updated: 2017-09-20

Locations

1 site across 1 country: Netherlands