Confocal Laser Endomicroscopy VERification

Part of paid clinical trials in New York, New York.

Sponsor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Study ID
NCT06079970
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Lung Neoplasm Malignant
  • Neoplasm of Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neelde Based Confocal Laser Endomicroscopy — DEVICE
    Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)
  • Conventional diagnostic bronchoscopy — PROCEDURE
    Conventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN AND/OR VB AND/OR ultrathin scope

Study Details

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.

Key Dates

Start date
Oct 18, 2023
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterNew YorkNew York10467
Ali Sadoughi, MD, DAABIP
Ali Sadoughi, MD, DAABIP (PRINCIPAL_INVESTIGATOR)

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By condition
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By research site
Montefiore Medical Center· New York, NY

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