Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

Completed · Not applicable

Conditions studied: Lung Nodule

In brief

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.

Key facts

Study ID

NCT04250194

Run by

Vanderbilt-Ingram Cancer Center

People needed

288

Starts

2020-05-22

Expected to finish

2024-07-02

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:
• Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:
• The Brock model14 if no PET scan data are available, or
• The Herder model15 if PET-CT data are available.
• Size between 10 and 30 mm (long diameter).
• Location peripheral, here defined as occupying the middle or outer third lung zones.
• Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.

You may not qualify if…

• 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.
• Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).

Where it is running

• University of California, San Diego — San Diego, California, United States
• Kootenai Health — Coeur d'Alene, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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