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

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.

Endpoints:

Primary:

• To evaluate diagnostic yield

Secondary:

• To evaluate rate of pneumothorax.
• To evaluate rate of pneumothorax requiring chest tube placement.
• To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
• To evaluate need for hospitalization after procedure.
• To evaluate duration of the procedure.
• To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
• To evaluate need for additional nodule biopsy.
• To evaluate need for additional procedure for staging.
• To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
• To evaluate need for F-Nav during navigation bronchoscopy.
• To evaluate bronchoscopy yield defined as the combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.