Clinical trial · Interventional
nCLE-Cone-beam CT Navigation Bronchoscopy
Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a Proof of Principle Study
- 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)
The goal of this proof of principle observational study is to investigate in patients with suspected peripheral pulmonary nodules. The main question it aims to answer is: • What is the concordance between CBCT navigation success (tool-in-lesion on CBCT spin) and nCLE tool-in-lesion confirmation (tool-in-lesion nCLE criteria observed). Participants scheduled to undergo a diagnostic conebeam navigation bronchoscopy will be included in the study. nCLE imaging at the tip of the TBNA needle will be added to the procedure for study purposes. Two needle punctures of the pulmonary nodule will be followed by nCLE imaging directly followed by a tool-in-lesion CBCT spin in order to compare nCLE results with CBCT results.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peripheral Lung Parenchyma Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| needle-based confocal laser endomicroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nCLE + CBCT-NB
- description
- Patients with a suspected malignant peripheral pulmonary nodule(s) referred for cone beam ct navigation bronchoscopy for tissue sampling.
- interventionNames
- Device: needle-based confocal laser endomicroscopy
Primary outcomes (1)
- measure
- CBCT navigation success and nCLE tool-in-lesion confirmation
- timeFrame
- Intra-procedure
- description
- CBCT-NB navigation success: tool-in-lesion OR unsuccessful navigation nCLE tool-in-lesion confirmation: in-lesion nCLE criteria seen
Secondary outcomes (7)
- measure
- Technical feasibility
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Suspected pulmonary nodule with an indication for CBCT-NB (decided by multidisciplinary tumour board) * Nodule must be solid or partially solid * Solid part of the nodule must be at least 8 mm * Largest dimension of the nodule on CT equal or less than 30 mm * Ability to understand and willingness to sign a written informed consent Exclusion Criteria: * Inability or non-willingness to provide informed consent * Patients with an endobronchial visible lung tumor on bronchoscopic inspection * Patients in which the target lesion is within reach of the linear EBUS scope * Lung nodules that resolved at the time of index intraprocedural CBCT * Failure to comply with the study protocol * Patients with known allergy for fluorescein or risk factors for an allergic reaction * Pregnant or breastfeeding women * Patients with hemodynamic instability * Patients with refractory hypoxemia * Patients with a therapeutic anticoagulant that cannot be held for an appropriate in-terval before the procedure * Patients who are unable to tolerate general anesthesia according to the anesthesiologist * Patient undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g. doxorubicin)
References
Publications (0)
Data not yet available