Mediastinal LymphadenopathyNCT02689050
Optical Biopsy for Thoracic Lymph Nodes.
An observational study of Mediastinal Lymphadenopathy and Non-small Cell Lung Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy, Non-small Cell Lung Carcinoma, Sarcoidosis
- What is being tested?
- Needle based confocal laser endomicroscopy (nCLE)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jan 2016to 22 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with suspected non-small cell lungcarcinoma/sarcoidosis scheduled for EUS-FNA.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum
Amsterdam, North Holland, 1105 AZ
About this study
Official title: 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.
Read the 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.
- Being tested
- Needle based confocal laser endomicroscopy (nCLE)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Needle based confocal laser endomicroscopy (nCLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: cross sectional (2 weeks)
The number of participants with procedure related adverse advents.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start13 Jan 2016
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mediastinal LymphadenopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jouke T Annema, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689050
- Sponsor's protocol ID
- NL54080.018.15
- Status last verified
- Sep 2017
- First submitted
- 28 Jan 2016
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: There is a plan to share nCLE results
Publications
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.
PubMed 37562791Wijmans 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.
PubMed 31075217
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.
- ClinicalTrials.gov ID
- NCT02689050
- Acronym / sponsor ID
- NL54080.018.15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lymphadenopathy | – | Device: Needle based confocal laser endomicroscopy (nCLE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected non-small cell lungcarcinoma/sarcoidosis scheduled for EUS-FNA.
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients with lymphadenopathy |
Primary outcome
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
2 secondary outcomes
Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis.
Time frame: cross sectional (2 weeks)
The number of participants with procedure related adverse advents.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Derived from this study: PubMed 37562791Kramer 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.
- Derived from this study: PubMed 31075217Wijmans 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.
- Individual participant dataSharing planned: Yes. There is a plan to share nCLE results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jouke T Annema, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Lymphadenopathy and Non-small Cell Lung Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689050, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.