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Confocal Laser Endomicroscopy for Lung Cancer
N/A
Recruiting
Led By Sebastian Fernandez-Bussy, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
First-pass diagnostic yield
Secondary outcome measures
Per-patient diagnostic yield
Other outcome measures
Clinical impact of needle-based confocal laser endomicroscopy (nCLE)
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.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,787 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,016 Total Patients Enrolled
Sebastian Fernandez-Bussy, M.D.Principal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung lesions could not be found or confirmed during surgery.You are allergic to fluorescein or have a high chance of having an allergic reaction.You cannot handle the type of anesthesia used for surgery, according to the doctor who gives the anesthesia.I have taken a beta-blocker within 24 hours before my lung procedure.I am on a blood thinner that can't be stopped for surgery.I am currently receiving chemotherapy.The procedure will stop if my blood pressure becomes unstable.I am 21 years old or older.Possible peripheral polyneuropathy.I have unstable blood pressure or heart issues.I have low oxygen levels in my blood that don't improve with treatment.The size of the nodule in the CT scan is between 8 mm and 30 mm at its longest dimension.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (EBUS TBNA)
- Group 2: Arm II (EBUS TBNA, nCLE, fluorescein)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still underway for this experiment?
"According to clinicaltrials.gov, the posting for this trial is no longer accepting patients; it was first uploaded on December 15th 2022 and last updated November 29th 2022. Nonetheless, there are 1507 other studies actively recruiting at present."
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