Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 17, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Mayo Clinic
- Interventions being studied
- Other: Fluorescein; Device: Image-Guided Needle Confocal Laser Endomicroscopy; Procedure: Ultrasound-Guided Transbronchial Needle Aspiration
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- \>= 21 years of age
- Suspected PPN
- Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension)
- Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
- Inability or non-willingness to provide informed consent
- Failure to comply with the study protocol
- Patients with known allergy for fluorescein or risk factors for an allergic reaction
- Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure
- Possibly pregnant, pregnant or breastfeeding women
- Patients with hemodynamic instability
- Patients with refractory hypoxemia
- Patients with a therapeutic anticoagulant that cannot be held for an appropriate interval before the procedure
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist
- Patient undergoing chemotherapy
- INTRA-OPERATIVE EXCLUSION/STOPPING CRITERIA:
- The lesions are unable to be localized/confirmed by bronchoscopy
- The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician
- The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic in FloridaJacksonville, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2025. Always confirm current availability with the study team.