Clinical trial · Observational
Optical Biopsy for Thoracic Lymph Nodes.
Needle Based CLE in Thoracic Lymph Nodes, a Comparison With Pathology.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mediastinal Lymphadenopathy | — | UNRESOLVED | — |
| Non-small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Sarcoidosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle based confocal laser endomicroscopy (nCLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with lymphadenopathy
- description
- 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.
- interventionNames
- Device: Needle based confocal laser endomicroscopy (nCLE)
Primary outcomes (1)
- measure
- The differences on CLE imaging between different disease entities in thoracic lymph nodes (e.g. malignant, reactive and nodes involved in sarcoidosis).
- timeFrame
- cross-sectional (2 weeks)
- description
- follow up of 2 weeks after measurements
Secondary outcomes (2)
- measure
- Creating a CLE-image atlas for reactive lymph nodes and lymph nodes involved in lung cancer and sarcoidosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKramer 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
- DERIVEDWijmans 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