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Optical Biopsy for Thoracic Lymph Nodes.

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ClinicalTrials.gov Identifier: NCT02689050
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment
Mediastinal Lymphadenopathy Non-small Cell Lung Carcinoma Sarcoidosis Device: Needle based confocal laser endomicroscopy (nCLE)

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : March 22, 2017
Actual Study Completion Date : March 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Group/Cohort Intervention/treatment
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)
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with suspected non-small cell lungcarcinoma/sarcoidosis scheduled for EUS-FNA.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689050


Locations
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Netherlands
Academisch Medisch Centrum
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Jouke T Annema, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)

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Responsible Party: Prof J.T. Annema, prof.dr J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02689050     History of Changes
Other Study ID Numbers: NL54080.018.15
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to share nCLE results

Additional relevant MeSH terms:
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Lung Neoplasms
Sarcoidosis
Carcinoma, Non-Small-Cell Lung
Lymphadenopathy
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms