Arm II (EBUS TBNA, nCLE, fluorescein) for Lung Cancer

Mayo Clinic in Florida, Jacksonville, FL
Lung CancerImage-Guided Needle Confocal Laser Endomicroscopy - Device
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Lung Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Clinical impact of needle-based confocal laser endomicroscopy (nCLE)
First-pass diagnostic yield
Per-patient diagnostic yield

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm I (EBUS TBNA)
1 of 2
Arm II (EBUS TBNA, nCLE, fluorescein)
1 of 2

Active Control

Experimental Treatment

118 Total Participants · 2 Treatment Groups

Primary Treatment: Arm II (EBUS TBNA, nCLE, fluorescein) · No Placebo Group · N/A

Arm II (EBUS TBNA, nCLE, fluorescein)Experimental Group · 3 Interventions: Image-Guided Needle Confocal Laser Endomicroscopy, Fluorescein, Ultrasound-Guided Transbronchial Needle Aspiration · Intervention Types: Device, Other, Procedure
Arm I (EBUS TBNA)
Procedure
ActiveComparator Group · 1 Intervention: Ultrasound-Guided Transbronchial Needle Aspiration · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,008 Previous Clinical Trials
3,513,351 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,280 Total Patients Enrolled
Sebastian Fernandez-BussyPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are suspected of having a condition called PPN.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.