Actively Recruiting
Confocal Laser Endomicroscopy VERification
Led by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) · Updated on 2026-04-07
208
Participants Needed
5
Research Sites
167 weeks
Total Duration
On this page
Sponsors
A
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Lead Sponsor
M
Mauna Kea Technologies
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Confocal Laser Endomicroscopy VERification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Suspected malignant peripheral lung lesion with indication for bronchoscopic diagnosis
- Bronchus sign on CT or confidence for navigation to nodule with radial EBUS
- Solid part of lesion at least 10 mm
- Largest lesion dimension on CT 30 mm or less
- Ability to understand and sign informed consent
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Visible endobronchial malignancy on bronchoscopy
- Lesion reachable by linear EBUS scope
- Non-compliance with study protocol
- Known allergy or risk for allergy to fluorescein
- Pregnancy or breastfeeding
- Hemodynamic instability
- Refractory low oxygen levels
- Use of anticoagulants that cannot be stopped before procedure
- Unable to tolerate general anesthesia
- Currently receiving chemotherapy with fluorescent drugs (e.g., doxorubicin)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Montefiore Medical Center
New York, New York, United States, 10467
Actively Recruiting
2
Vienna General Hospital
Vienna, Austria
Actively Recruiting
3
General University Hospital Prague
Prague, Czechia
Actively Recruiting
4
Sotiria Hospital
Athens, Greece
Actively Recruiting
5
Amsterdam University Medical Centers
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
Research Team
S
Saskia van Heumen, MSc
CONTACT
J
Jouke Annema, Prof. dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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