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NCT Number: NCT02689050

Optical Biopsy for Thoracic Lymph Nodes.

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.

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Key information

Conditions

Mediastinal Lymphadenopathy Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Site Non-small Cell Lung Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoidosis Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Needle based confocal laser endomicroscopy (nCLE)

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis.

    Time frame: cross sectional (2 weeks)

  2. The number of participants with procedure related adverse advents.

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2016
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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