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

Lung Nodule Clinical Trial

Official title: Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Lung Nodule

• NCT number: NCT04250194
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2020
• Completion date: July 31, 2025