Needle-based laser imaging during bronchoscopy for suspicious lung nodules
Tests whether adding needle-based laser imaging to bronchoscopy helps diagnose suspicious lung nodules in adults.
Plain-language title generated from the registry record
Registry title: Confocal Laser Endomicroscopy VERification
Key facts
- Where
- Vienna, AustriaSee the site
Where in Austria
- Vienna General HospitalVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Trial code
- NCT06079970
- Record updated
- 7 April 2026
- Original description
The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy.Read full original descriptionShow less
Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)
The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy.
The main question[s] it aims to answer are:
To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion 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).
Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.
Inclusion: ≥18 years of age; Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy; Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal; Solid part of the lesion must be ≧10 mm; Largest dimension of lesion size on CT ≦30 mm (long-axis); Ability to understand and willingness to sign a written informed consent.
Exclusion: Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin); Endobronchial visible malignancy on bronchoscopic inspection; Failure to comply with the study protocol; Known allergy or risk factors for an allergic reaction to fluorescein; Inability or non-willingness to provide informed consent; Target lesion within reach of the linear EBUS scope; Pregnancy or breastfeeding; Hemodynamic instability; Refractory hypoxemia; Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure; Unable to tolerate general anesthesia according to the anesthesiologist.