RecruitingNot applicableNCT06079970

Confocal Laser Endomicroscopy VERification

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.

Checked against the public recordLast updated Apr 7, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhaseNot applicable
U.S. locations5
SponsorAmsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Interventions being studied
Device: Neelde Based Confocal Laser Endomicroscopy; Procedure: Conventional diagnostic bronchoscopy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. ≥18 years of age 2. 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 3. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal 4. Solid part of the lesion must be ≧10 mm 5. Largest dimension of lesion size on CT ≦30 mm (long-axis) 6. Ability to understand and willingness to sign a written informed consent Exclusion Criteria: 1. Inability or non-willingness to provide informed consent 2. Endobronchial visible malignancy on bronchoscopic inspection 3. Target lesion within reach of the linear EBUS scope 4. Failure to comply with the study protocol 5. Known allergy or risk factors for an allergic reaction to fluorescein 6. Pregnancy or breastfeeding 7. Hemodynamic instability 8. Refractory hypoxemia 9. Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure 10. Unable to tolerate general anesthesia according to the anesthesiologist 11. Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Montefiore Medical CenterNew York, New York
  • Vienna General HospitalVienna
  • General University Hospital PraguePrague
  • Sotiria HospitalAthens
  • Amsterdam University Medical CentersAmsterdam

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 7, 2026. Always confirm current availability with the study team.

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