TerminatedNot Applicable

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

Stopped: Slow accrual

United States3 participantsStarted 2023-05-12

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>= 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

First-pass Diagnostic Yield

Timeframe: Baseline

Trial details

NCT IDNCT05556525

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-03

Results submitted2025-08-11

View on ClinicalTrials.gov More Lung Carcinoma trials