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Optical Biopsy for Thoracic Lymph Nodes.

NCT ID: NCT02689050

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-13

Study Completion Date

2017-03-22

Brief Summary

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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

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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.

Conditions

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Mediastinal Lymphadenopathy Non-small Cell Lung Carcinoma Sarcoidosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Needle based confocal laser endomicroscopy (nCLE)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Prof J.T. Annema

prof.dr J.T. Annema

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jouke T Annema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)

Locations

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Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 37562791 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31075217 (View on PubMed)

Other Identifiers

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NL54080.018.15

Identifier Type: -

Identifier Source: org_study_id