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
- Prague, CzechiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a small spot in the outer part of the lung that may be cancer and who need a bronchoscopy to find out. Everyone has a bronchoscopy, some with an extra imaging method.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- A suspected cancerous lung spot in the outer lung, beyond the visible airways. The solid part is at least 10 mm and the largest size on CT is at most 30 mm.
- Earlier treatment
- Must not be having chemotherapy now. Blood thinners that cannot be paused before the procedure are not allowed.
- Biomarker or test result
- A bronchus sign on the CT scan before the procedure, or a good chance of reaching the spot so that a radial EBUS signal is seen.
Main reasons for not taking part
- A cancer that can be seen inside the airway during bronchoscopy
- A lung spot that the linear EBUS scope can reach
- Allergy or allergy risk to fluorescein
- Pregnancy or breastfeeding
- Unstable circulation, refractory low blood oxygen, or unable to tolerate general anesthesia
Read by machine on 12 November 2026.
Where in Czechia
- General University Hospital PraguePrague, CzechiaContact: Zuzana ŠestákováTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.