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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Jouke Annema, MD, PhD
j.t.annema@amsterdamumc.nl
+31(0)20 566 2694
Backup
Saskia van Heumen, MSc
s.vanheumen@amsterdamumc.nl
+31(0)20 566 2694
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2025-07
Participants
Target number of participants: 25
Treatments
Experimental: nCLE + CBCT-NB
Patients with a suspected malignant peripheral pulmonary nodule(s) referred for cone beam ct navigation bronchoscopy for tissue sampling.
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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