NCLE-Cone-beam CT Navigation Bronchoscopy
Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a Proof of Principle Study
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
25 participants
Oct 8, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria12
- 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)
Interventions
needle-based confocal laser endomicroscopy at the tip of the TBNA needle for two punctures, combined with confirmatory CBCT spin for tool-in-lesion confirmation
Locations(1)
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NCT06505642