Optical Biopsy for Thoracic Lymph Nodes.

Sarcoidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689050
• Other study ID #: NL54080.018.15
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: September 19, 2017
• Start date: January 13, 2016
• Est. completion date: March 22, 2017

Study information

• Verified date: September 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Lymphatic Diseases
• Mediastinal Lymphadenopathy
• Non-small Cell Lung Carcinoma
• Sarcoidosis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

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