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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CBCT navigation success and nCLE tool-in-lesion confirmation
Timeframe: Intra-procedure
Trial details
NCT IDNCT06505642
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)