Optical Biopsy for Thoracic Lymph Nodes.

NCT02689050 | Completed

• 1 other identifier: NL54080.018.15
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediastinal Lymphadenopathy; Non-small Cell Lung Carcinoma; Sarcoidosis

Outcome Measures

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).

  follow up of 2 weeks after measurements

  cross-sectional (2 weeks)

Secondary Outcomes (2)

• 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

Study Arms (1)

Patients with lymphadenopathy

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.

Device: Needle based confocal laser endomicroscopy (nCLE)

Interventions

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.

Patients with lymphadenopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with suspected non-small cell lungcarcinoma/sarcoidosis scheduled for EUS-FNA.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (2)

• Kramer T, Wijmans L, van Heumen S, Bansal S, Jeannerat D, Manley C, de Bruin M, Bonta PI, Annema JT. Needle-based confocal laser endomicroscopy for real-time granuloma detection. Respirology. 2023 Oct;28(10):934-941. doi: 10.1111/resp.14542. Epub 2023 Aug 10.

  PMID: 37562791 DERIVED

• 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.

  PMID: 31075217 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Sarcoidosis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Jouke T Annema, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr J.T. Annema

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 23, 2016
• Study Start: January 13, 2016
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)