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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Navigation Endoscopy for the Diagnosis of Indeterminate Lung Nodules, VERITAS Study

This trial studies how well navigation endoscopy works in diagnosing indeterminate lung nodules. Navigation bronchoscopy is a procedure using technology designed to guide a flexible bronchoscope (a small tube with a camera) through the natural airway route (wind-pipe and bronchi) to access the nodule. Navigation bronchoscopy may be more accurate than the standard computed tomography (CT)-guided biopsy in diagnosing patients with indeterminate lung nodules.
Lung
N/A
Adults
Therapy (NOS)
Not Available
Maldonado, Fabien
Local
Vanderbilt University
05-21-2020
Diagnostic
VICCTHO19102
NCT04250194

Eligibility

18 Years
BOTH
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 or high 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 model if no positron emission tomography (PET) scan data are available, or ** The Herder model 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 ** Note: Prior to randomization, the main purpose of this study-provided central review is to establish panel agreement with local expertise offered by the participating study site, that local management of a consented candidate patient at the site can be achieved by standard of care navigation bronchoscopy or equally achieved by standard of care CT-guided biopsy (with either procedure able to be performed at the local institution)



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)

Radiologically abnormal mediastinal or hilar lymph nodes requiring endobronchial ultrasound

Patients for whom stereotactic body radiation therapy is planned even if biopsies show no evidence of malignancy

Patients with contraindication to biopsy or deep sedation/general anesthesia

Patients unable or unwilling to comply with study follow-up schedule

Patients previously randomized to the study

Patients unable to provide written informed consent

Patients who are nursing or pregnant as verified by an optional standard of care pregnancy test. (Testing required only if deemed clinically necessary by the patient’s study physician)

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