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

Conditions

• Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorescein — OTHER
  Given IV
• Image-Guided Needle Confocal Laser Endomicroscopy — DEVICE
  Undergo nCLE
• Ultrasound-Guided Transbronchial Needle Aspiration — PROCEDURE
  Undergo EBUS TBNA

Study Details

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.

Key Dates

Start date

May 12, 2023

Status verified

Jul 2025

Primary completion

Jun 3, 2024

Completion

Oct 25, 2024

Study Design

Enrollment

3 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Arm I (EBUS TBNA)
  Patients undergo robotic EBUS TBNA on study.
• Experimental: Arm II (EBUS TBNA, nCLE, fluorescein)
  Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study.

Primary Outcome Measure

First-pass Diagnostic Yield [ Time Frame: Baseline ]

Locations (1)

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