Optical Biopsy for Thoracic Lymph Nodes.

Completed

• Conditions: Non-small Cell Lung Carcinoma; Sarcoidosis; Mediastinal Lymphadenopathy
• Interventions: Device: Needle based confocal laser endomicroscopy (nCLE)

• Registration Number: NCT02689050
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Study Timeline

• Study Start: 2016-01-13
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Primary Completion: 2017-03-22
• Study Completion: 2017-03-22
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with lymphadenopathy	Needle based confocal laser endomicroscopy (nCLE)	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.

Primary Outcome Measures

Name	Time	Method
The differences on CLE imaging between different disease entities in thoracic lymph nodes (e.g. malignant, reactive and nodes involved in sarcoidosis).	cross-sectional (2 weeks)	follow up of 2 weeks after measurements

Secondary Outcome Measures

Name	Time	Method
Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis.	cross sectional (2 weeks)
The number of participants with procedure related adverse advents.	2 weeks

Trial Locations

Locations (1)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Noord-Holland, Netherlands