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Confocal Laser Endomicroscopy for Lung Cancer

N/A
Recruiting
Led By Sebastian Fernandez-Bussy
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 21 years of age
Be older than 18 years old
Must not have
INTRA-OPERATIVE EXCLUSION/STOPPING CRITERIA: The lesions are unable to be localized/confirmed by bronchoscopy
Patient undergoing chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether using a needle-based laser to get real-time images of tissue during a bronchoscopy, along with the dye fluorescein, is better than just using the bronchoscopy alone for diagnosing lung cancer in patients with peripheral pulmonary nodules.

Who is the study for?
This trial is for adults over 21 who suspect they have lung cancer with nodules sized between 8-30mm on a CT scan. They must understand and sign consent forms, not be pregnant or breastfeeding, and can't have used beta-blockers or certain anticoagulants recently. Those allergic to fluorescein or unable to tolerate general anesthesia are excluded.
What is being tested?
The study tests if using needle-based confocal laser endomicroscopy (nCLE) with an imaging agent called fluorescein alongside standard EBUS TBNA improves lung cancer diagnosis in patients with peripheral pulmonary nodules compared to just EBUS TBNA.
What are the potential side effects?
Potential side effects may include allergic reactions to fluorescein, complications from the bronchoscopic procedure like bleeding or infection, and issues related to general anesthesia such as nausea or breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung lesions could not be found or confirmed during surgery.
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I am currently receiving chemotherapy.
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I have unstable blood pressure or heart issues.
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I have low oxygen levels in my blood that don't improve with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
First-pass diagnostic yield
Secondary study objectives
Per-patient diagnostic yield
Other study objectives
Clinical impact of needle-based confocal laser endomicroscopy (nCLE)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (EBUS TBNA, nCLE, fluorescein)Experimental Treatment3 Interventions
Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study.
Group II: Arm I (EBUS TBNA)Active Control1 Intervention
Patients undergo robotic EBUS TBNA on study.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,462 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,006 Total Patients Enrolled
Sebastian Fernandez-BussyPrincipal InvestigatorMayo Clinic
Sebastian Fernandez-Bussy, M.D.Principal InvestigatorMayo Clinic

Media Library

Ultrasound-Guided Transbronchial Needle Aspiration Clinical Trial Eligibility Overview. Trial Name: NCT05556525 — N/A
Lung Cancer Research Study Groups: Arm I (EBUS TBNA), Arm II (EBUS TBNA, nCLE, fluorescein)
Lung Cancer Clinical Trial 2023: Ultrasound-Guided Transbronchial Needle Aspiration Highlights & Side Effects. Trial Name: NCT05556525 — N/A
Ultrasound-Guided Transbronchial Needle Aspiration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556525 — N/A
~20 spots leftby May 2025
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