NCT06505642Active, not recruiting
nCLE-Cone-beam CT Navigation Bronchoscopy
Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a Proof of Principle Study
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- 8 Oct 2024
- Primary completion date
- 16 Dec 2025
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Lung cancer
- NCT number
- NCT06505642
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 8 Oct 2024 to the primary completion date, 16 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g. doxorubicin)
Other illness
- Failure to comply with the study protocol
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.