RecruitingNot ApplicableNCT06505642

NCLE-Cone-beam CT Navigation Bronchoscopy

Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a Proof of Principle Study

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

25 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Lung Neoplasm Peripheral Lung Parenchyma Tumor

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a bronchoscopy technique (going through the airways with a camera) guided by cone-beam CT — a type of real-time 3D X-ray — to take tissue samples from small lung nodules. The aim is to find out how accurate and safe this method is for diagnosing lung cancer from hard-to-reach nodules. **You may be eligible if...** - You are 18 or older with a lung nodule that your medical team has recommended for bronchoscopic biopsy - The nodule is solid or partially solid, at least 8 mm in solid size, and no larger than 30 mm overall - You are able to tolerate general anesthesia **You may NOT be eligible if...** - You have a visually obvious tumor in your airway - Your nodule is close enough to be reached by standard ultrasound bronchoscopy (EBUS) - You have a known allergy to fluorescein (a dye used in the procedure) - You are pregnant or breastfeeding - You have unstable heart or breathing issues that make bronchoscopy unsafe - You take blood thinners that cannot be safely paused Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEneedle-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