nCLE-Cone-beam CT Navigation Bronchoscopy
NCT Number: NCT06505642
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Neoplasm|Peripheral Lung Parenchyma Tumor|Lung Cancer
Interventions: DEVICE: needle-based confocal laser endomicroscopy
Sponsor: Amsterdam UMC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11
Completion Date: 2025-07
Locations: Amsterdam UMC, Amsterdam, Netherlands

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.

Primary Outcome Measures: CBCT navigation success and nCLE tool-in-lesion confirmation, CBCT-NB navigation success: tool-in-lesion OR unsuccessful navigation nCLE tool-in-lesion confirmation: in-lesion nCLE criteria seen, Intra-procedure
Secondary Outcome Measures: Technical feasibility, Proportion of nCLE imaging that are successful (meaning that the preloaded needle can be advanced through the working channel, puncture the nodule, advance the CLE probe and start imaging) resulting good quality images., Intra-procedure|Safety, Number and proportion of (severe) adverse events ((S)AEs) and investigational procedure related adverse events (AEs), Up to 7 days post procedure|Diagnostic yield, Proportion (expressed in percentages) of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure., up to 6 months post procedure|Diagnostic sensitivity for malignancy, Proportion (expressed in percentages) of patients that have malignancy diagnosed by bronchoscopic tissue sampling, relative to the total number of patients with a final diagnosis of malignancy as determined by the reference standard., up to 6 months post procedure|Sensitivity, specificity and accuracy of real-time nCLE imaging assessment, Sensitivity, specificity and accuracy of real-time nCLE imaging assessment all described in percentages., Intra-procedure|Sensitivity, specificity and accuracy of post-procedure nCLE image assessment, Sensitivity, specificity and accuracy of post-procedure nCLE image assessment described as percentages., Intra-procedure|Interobserver agreement (IOA) and intraobserver reliability (IOR), Interobserver agreement (IOA) represented by the Cohen's kappa statistics (mean with 95% confidence intervall) and intraobserver reliability (IOR) represented by the Cohen's kappa statistics (mean +/- standard deviation), Intra-procedure
Other Outcome Measures: Total procedure duration, Total procedure duration in minutes (introduction brochoscope to removal of bronchoscope), Intra-procedure