Confocal Laser Endomicroscopy VERification

Description

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

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Study Overview

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Study Details

Study overview

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.

Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)

Confocal Laser Endomicroscopy VERification

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

New York

Montefiore Medical Center, New York, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Jouke Annema, Prof. dr., PRINCIPAL_INVESTIGATOR, Amsterdam UMC

Study Record Dates

2025-10-18