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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
288
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
A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy
University of California, San Diego
San Diego, California, United States
Kootenai Health
Coeur d'Alene, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Diagnostic Accuracy
Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following: * Malignant, OR * Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR * Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND * Absence of malignancy (true negative) through 1-year CT follow-up, defined as: * The nodule markedly regresses or resolves on follow-up imaging, OR * A persistent nodule has not been diagnosed as malignant, AND * No plans for repeat invasive diagnostic procedures through 12 months follow-up. Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.
Time frame: Up to 12 months
Diagnostic Yield
Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.
Time frame: Up to 12 months
Rate of Pneumothorax
Proportion of cases complicated by pneumothorax
Time frame: Up to 12 months
Rate of Pneumothorax Requiring Chest Tube Placement
Proportion of cases complicated by pneumothorax requiring chest tube placement
Time frame: Up to 12 months
Need for Hospitalization After Procedure
Proportion of cases with complication necessitating hospitalization after a procedure
Time frame: Up to 12 months
Duration of Procedure
Total time required to complete the procedure
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy)
Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Number of Biopsies)
Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)
Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)
Association of diagnostic yield with presence of a bronchus sign
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Biopsy Site)
Association of diagnostic yield with biopsy site (nodule location)
Time frame: Up to 12 months
Need for Additional Nodule Biopsy
Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed
Time frame: Up to 12 months
Need for Additional Procedure for Staging
Proportion of cases in which a subsequent procedure was performed for staging
Time frame: Up to 12 months
Radiation Exposure From Fluoroscopy-guided Bronchoscopy
Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy\*cm\^2)
Time frame: Up to 12 months
Need for F-Nav During Navigation Bronchoscopy
Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.
Time frame: Up to 12 months
Confident Clinical Diagnosis
The proportion of biopsy procedures yielding 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.
Time frame: Up to 12 months
Radiation Exposure From CT for CT-guided Biopsy
Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy\*cm)
Time frame: Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group
Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.
Time frame: Up to 12 months
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