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

Study Overview
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Brief Summary
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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: 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 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.

Detailed Description
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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.

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

Conditions
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Lung Nodule

Intervention / Treatment
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* Device: CT-Guided Biopsy
* Device: Navigation bronchoscopy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation Bronchoscopy (NB) with F-Nav<br> | Device: Navigation bronchoscopy<br>* A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy<br>|
| Experimental: CT-guided Biopsy<br> | Device: CT-Guided Biopsy<br>* Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Rate of technically successful biopsies leading to a definitive diagnosis | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pneumothorax | Number of instances of pneumothorax | Up to 12 months | 
| Rate of pneumothorax requiring chest tube placement | Number of instances of pneumothorax requiring chest tube placement | Up to 12 months | 
| Need for hospitalization after procedure | Number of instances of hospitalization after a procedure | Up to 12 months | 
| Duration of procedure | Total time required to complete the procedure | Up to 12 months | 
| Procedural factors associated with improved yield (type of biopsy) | Count of type of biopsy | Up to 12 months | 
| Procedural factors associated with improved yield (number of biopsies) | Count of biopsies | Up to 12 months | 
| Procedural factors associated with improved yield (use of radial ultrasound) | Number of instances of use of radial ultrasound | Up to 12 months | 
| Procedural factors associated with improved yield (presence of a bronchus sign) | Count of presence of a bronchus sign | Up to 12 months | 
| Procedural factors associated with improved yield (biopsy site) | Count of biopsy site | Up to 12 months | 
| Need for additional nodule biopsy | Count of instances of need for an additional nodule biopsy | Up to 12 months | 
| Need for additional procedure for staging | Count of instances of need of an additional procedure for staging | Up to 12 months | 
| Radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy | Count of total radiation exposure from fluoroscopy-guided bronchoscopy | Up to 12 months | 
| Radiation exposure from CT-guided biopsy | Count of total radiation exposure from fluoroscopy-guided bronchoscopy | Up to 12 months | 
| Need for F-Nav during navigation bronchoscopy | Count of instances of need for F-Nav during navigation bronchoscopy | Up to 12 months | 
| Bronchoscopy yield | The combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies. | Up to 12 months |