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

Recruiting in Palo Alto (17 mi)

+6 other locations

Maldonado [142102] | Vanderbilt-Ingram ...

Overseen ByFabien Maldonado, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt-Ingram Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy: 1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and 2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.

Eligibility Criteria

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.

Inclusion Criteria

My lung cancer is located in the outer or middle part of my lungs.

Exclusion Criteria

My lung nodules are not in the top third of my lung.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Navigation Bronchoscopy (NB) with F-NavExperimental Treatment1 Intervention

Group II: CT-guided BiopsyExperimental Treatment1 Intervention