Optical Biopsy for Thoracic Lymph Nodes.
September 19, 2017 updated by: Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1105 AZ
- Academisch Medisch Centrum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with suspected non-small cell lungcarcinoma/sarcoidosis scheduled for EUS-FNA.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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follow up of 2 weeks after measurements
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cross-sectional (2 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis.
Time Frame: cross sectional (2 weeks)
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cross sectional (2 weeks)
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The number of participants with procedure related adverse advents.
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jouke T Annema, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2016
Primary Completion (Actual)
March 22, 2017
Study Completion (Actual)
March 22, 2017
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
February 18, 2016
First Posted (Estimate)
February 23, 2016
Study Record Updates
Last Update Posted (Actual)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 19, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL54080.018.15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
There is a plan to share nCLE results
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.