Clinical trial NCT02689050: Optical Biopsy for Thoracic Lymph Nodes.
Official title: Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mediastinal Lymphadenopathy
Non-small Cell Lung Carcinoma
Sarcoidosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected non-small cell lungcarcinoma/sarcoidosis scheduled for EUS-FNA.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The differences on CLE imaging between different disease entities in thoracic lymph nodes (e.g. malignant, reactive and nodes involved in sarcoidosis).
timeFrame: cross-sectional (2 weeks)
Secondary outcomes:
measure: Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis.
timeFrame: cross sectional (2 weeks)
measure: The number of participants with procedure related adverse advents.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)
name: Jouke T Annema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wijmans L, Baas P, Sieburgh TE, de Bruin DM, Ghuijs PM, van de Vijver MJ, Bonta PI, Annema JT. Confocal Laser Endomicroscopy as a Guidance Tool for Pleural Biopsies in Malignant Pleural Mesothelioma. Chest. 2019 Oct;156(4):754-763. doi: 10.1016/j.chest.2019.04.090. Epub 2019 May 7.