Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Phase
Not applicable
Started
2023-10-18
Last updated
2026-04-07
Condition(s) studied
Lung CancerLung Neoplasm MalignantCarcinoma, Non-Small-Cell LungNeoplasm of Lung
Investigational drug(s) / intervention(s)
Neelde Based Confocal Laser EndomicroscopyConventional diagnostic bronchoscopy
Neelde Based Confocal Laser Endomicroscopy: Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)
Conventional diagnostic bronchoscopy: Conventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN AND/OR VB AND/OR ultrathin scope
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Diagnostic yield (intermediate definition) — After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years) Diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis \[either malignant, specific benign or non-specific benign confirmed as benign in follow-up\], relative to the total number of patients that underwent the diagnostic bronchoscopic procedure). If patients with multiple lesions are included, the diagnostic yield will be computed per nodule.
Trial sites (5)
Facility
City
Region
Status
Montefiore Medical Center
New York
New York
Recruiting
Vienna General Hospital
Vienna
Austria
Recruiting
General University Hospital Prague
Prague
Czechia
Recruiting
Sotiria Hospital
Athens
Greece
Recruiting
Amsterdam University Medical Centers
Amsterdam
Netherlands
Recruiting
More Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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