Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
Purpose
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.
Condition
- Lung Nodule
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Navigation Bronchoscopy (NB) with F-Nav |
|
|
|
Experimental CT-guided Biopsy |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
Detailed 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.