Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules
Reason given: Slow accrual
Key facts
- Where
- Jacksonville, United StatesSee the site
Where in United States
- Mayo Clinic in FloridaJacksonville, United StatesNo longer taking part
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT05556525
- Record updated
- 17 September 2025
- Original description
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.Read full original descriptionShow less
nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis
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.
Inclusion: >= 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.
Exclusion: Patient undergoing chemotherapy; Failure to comply with the study protocol; Patients with known allergy for fluorescein or risk factors for an allergic reaction; Inability or non-willingness to provide informed consent; 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; 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.