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

  • End date
    Sep 28, 2024
  • participants needed
  • sponsor
    Vanderbilt-Ingram Cancer Center
Updated on 6 December 2021


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.



To evaluate diagnostic yield

  • 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.

Condition Lung Nodule
Treatment CT-Guided Biopsy, Navigation bronchoscopy
Clinical Study IdentifierNCT04250194
SponsorVanderbilt-Ingram Cancer Center
Last Modified on6 December 2021


Yes No Not Sure

Inclusion Criteria

Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of
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

Exclusion Criteria

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)
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