NCT06079970Recruiting
Confocal Laser Endomicroscopy VERification
Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- First submitted
- 2 Oct 2023
- Start date
- 18 Oct 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Diseases
- Lung cancer
- NCT number
- NCT06079970
What you commit to
- Study type: Interventional
- Planned participants: 208
- From 18 Oct 2023 to the primary completion date, 31 Dec 2026
- 5 sites in 5 countries
- 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)
Other illness
- Endobronchial visible malignancy on bronchoscopic inspection
- Failure to comply with the study protocol
- Known allergy or risk factors for an allergic reaction to fluorescein
Other
- 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
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vienna General Hospital Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| General University Hospital Prague Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Sotiria Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Amsterdam University Medical Centers Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.