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

Vanderbilt University Medical Center

Status: Completed

Conditions: Lung Nodule

Treatments: Device: CT-Guided Biopsy; Device: Navigation bronchoscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04250194

VICC THO 19102

NCI-2020-00632 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Endpoints:

Primary:

• To evaluate diagnostic accuracy through 12 months of clinical follow-up

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 (digital tomosynthesis) during navigation bronchoscopy.
• To evaluate diagnostic yield
• To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

Navigation Bronchoscopy (NB) with F-Nav

Experimental group

Treatment:

Device: Navigation bronchoscopy

CT-guided Biopsy

Experimental group

Treatment:

Device: CT-Guided Biopsy