Lung NeoplasmPeripheral Lung Parenchyma TumorLung Cancer
Investigational drug(s) / intervention(s)
needle-based confocal laser endomicroscopy
needle-based confocal laser endomicroscopy: 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
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
CBCT navigation success and nCLE tool-in-lesion confirmation — Intra-procedure CBCT-NB navigation success: tool-in-lesion OR unsuccessful navigation nCLE tool-in-lesion confirmation: in-lesion nCLE criteria seen
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC
Amsterdam
Netherlands
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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