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Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules

NCT05556525 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-17

Study results available
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Summary

This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.

Conditions

  • Lung Carcinoma

Interventions

OTHER

Fluorescein

Given IV

DEVICE

Image-Guided Needle Confocal Laser Endomicroscopy

Undergo nCLE

PROCEDURE

Ultrasound-Guided Transbronchial Needle Aspiration

Undergo EBUS TBNA

Sponsors & Collaborators

Principal Investigators

  • Sebastian Fernandez-Bussy, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2024-06-03
Completion
2024-10-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05556525 on ClinicalTrials.gov