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Navigation Bronchoscopy vs CT-Guided Biopsy for Lung Nodules (VERITAS Trial)

N/A
Waitlist Available
Led By Fabien Maldonado, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Location peripheral, here defined as occupying the middle or outer third lung zones.
Be older than 18 years old
Must not have
Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This trial will compare which of the two procedures, CT-guided biopsy or navigation bronchoscopy, is better for patients referred for biopsy of a lung nodule.

Who is the study for?
This trial is for patients with a single lung nodule sized between 10 and 30 mm, located in the middle or outer parts of the lungs. They should have an intermediate chance of cancer (10-100%) based on specific prediction models. The nodule must be reachable by both navigation bronchoscopy and CT-guided biopsy as confirmed by experts.
What is being tested?
The study compares two procedures to biopsy lung nodules: navigation bronchoscopy, which uses airways to reach the growth, and CT-guided biopsy, where a needle goes through the chest wall with CT scan guidance. It aims to find out which method is best for certain lung nodules.
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, bleeding within the lung (hemoptysis), collapsed lung (pneumothorax), infection risk from invasive procedures, and possible allergic reactions to local anesthesia used during biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is located in the outer or middle part of my lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My lung nodules are not in the top third of my lung.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic yield
Secondary outcome measures
Bronchoscopy yield
Duration of procedure
Need for F-Nav during navigation bronchoscopy
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Navigation Bronchoscopy (NB) with F-NavExperimental Treatment1 Intervention
Group II: CT-guided BiopsyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
214 Previous Clinical Trials
60,737 Total Patients Enrolled
MedtronicIndustry Sponsor
611 Previous Clinical Trials
828,633 Total Patients Enrolled
Fabien Maldonado, MD5.02 ReviewsPrincipal Investigator - Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
5 Previous Clinical Trials
4,438 Total Patients Enrolled

Media Library

CT-Guided Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04250194 — N/A
Lung Nodules Research Study Groups: Navigation Bronchoscopy (NB) with F-Nav, CT-guided Biopsy
Lung Nodules Clinical Trial 2023: CT-Guided Biopsy Highlights & Side Effects. Trial Name: NCT04250194 — N/A
CT-Guided Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04250194 — N/A
~49 spots leftby Sep 2025
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