Recruiting

Confocal Laser Endomicroscopy

Sponsor:

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Code:

NCT06079970

Conditions

Lung Cancer

Lung Neoplasm Malignant

Carcinoma, Non-Small-Cell Lung

Neoplasm of Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neelde Based Confocal Laser Endomicroscopy

Conventional diagnostic bronchoscopy

Study Details

Brief 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.

Conditions

Lung Cancer

Lung Neoplasm Malignant

Carcinoma, Non-Small-Cell Lung

Neoplasm of Lung

Study ID

NCT06079970

Start date

Oct 18, 2023

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: nCLE arm

Diagnostic bronchoscopy is done according to institutional practice with the addition of nCLE

active comparator: Control arm

Diagnostic bronchoscopy is done according to institutional practice without the addition of nCLE

Interventions

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

Primary outcome measure

  • Diagnostic yield (intermediate definition) [ Time Frame: After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years) ]

Central Contacts and Locations

Central contacts

Locations

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Principal Investigator:

Ali Sadoughi, MD, DAABIP

More Information

Sponsor

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Last update posted

Apr 7, 2026

Last verified

Apr, 2025

Keywords

  • Confocal Microscopy
  • Bronchoscopy
  • Confocal laser endomicroscopy
  • CLE
  • Fluoroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) on 2026-04-07.