Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06079970

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here