Lung Nodule
Conditions
Brief summary
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.
Detailed 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).
Interventions
DEVICECT-Guided Biopsy
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
DEVICENavigation bronchoscopy
A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy
Sponsors
Medtronic
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Pneumothorax | Up to 12 months | Proportion of cases complicated by pneumothorax |
| Rate of Pneumothorax Requiring Chest Tube Placement | Up to 12 months | Proportion of cases complicated by pneumothorax requiring chest tube placement |
| Need for Hospitalization After Procedure | Up to 12 months | Proportion of cases with complication necessitating hospitalization after a procedure |
| Duration of Procedure | Up to 12 months | Total time required to complete the procedure |
| Procedural Factors Associated With Improved Yield (Type of Biopsy) | Up to 12 months | 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. |
| Procedural Factors Associated With Improved Yield (Number of Biopsies) | Up to 12 months | Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm. |
| Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Up to 12 months | Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm. |
| Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) | Up to 12 months | Association of diagnostic yield with presence of a bronchus sign |
| Diagnostic Yield | Up to 12 months | 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. |
| Need for Additional Nodule Biopsy | Up to 12 months | Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed |
| Need for Additional Procedure for Staging | Up to 12 months | Proportion of cases in which a subsequent procedure was performed for staging |
| Radiation Exposure From Fluoroscopy-guided Bronchoscopy | Up to 12 months | Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy\*cm\^2) |
| Need for F-Nav During Navigation Bronchoscopy | Up to 12 months | Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm. |
| Confident Clinical Diagnosis | Up to 12 months | 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. |
| Radiation Exposure From CT for CT-guided Biopsy | Up to 12 months | Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy\*cm) |
| Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Up to 12 months | 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. |
| Procedural Factors Associated With Improved Yield (Biopsy Site) | Up to 12 months | Association of diagnostic yield with biopsy site (nodule location) |
Countries
United States
Participant flow
Pre-assignment details
288 participants were consented, 30 participants were excluded prior to randomization: * Failed central adjudication of procedure feasibility (n=20) * Withdrawal of informed consent (n=5) * New data available meeting exclusion criterion (n=5)
Participants by arm
| Arm | Count |
|---|---|
| Navigation Bronchoscopy (NB) With F-Nav Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy | 121 |
| CT-guided Biopsy CT-Guided Biopsy: 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 | 113 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined to schedule biopsy | 6 | 10 |
| Overall Study | Medically Unfit for Biopsy | 2 | 1 |
| Overall Study | New data available meeting exclusion criterion: interim CT demonstrated rapid growth to >30 mm | 0 | 2 |
| Overall Study | New data available meeting exclusion criterion: PET/CT with avid adenopathy | 0 | 2 |
| Overall Study | New data available meeting exclusion criterion: PET/CT with avid endobronchial lesion | 0 | 1 |
Baseline characteristics
| Characteristic | CT-guided Biopsy | Total | Navigation Bronchoscopy (NB) With F-Nav |
|---|---|---|---|
| Age, Continuous | 68 years | 67 years | 66 years |
| Body Mass Index | 27.9 kg/m^2 | 27.7 kg/m^2 | 27.6 kg/m^2 |
| Comorbidities Chronic Obstructive Pulmonary Disease (COPD) | 48 Participants | 97 Participants | 49 Participants |
| Comorbidities Coronary artery disease | 16 Participants | 41 Participants | 25 Participants |
| Comorbidities Current or prior malignancy | 55 Participants | 101 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 231 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pack-years | 35 pack-years | 40.0 pack-years | 43 pack-years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 105 Participants | 215 Participants | 110 Participants |
| Sex: Female, Male Female | 56 Participants | 113 Participants | 57 Participants |
| Sex: Female, Male Male | 57 Participants | 121 Participants | 64 Participants |
| Tobacco smoking history Current | 24 Participants | 63 Participants | 39 Participants |
| Tobacco smoking history Former | 66 Participants | 121 Participants | 55 Participants |
| Tobacco smoking history Non-smoker | 23 Participants | 50 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 113 |
| other Total, other adverse events | 4 / 121 | 19 / 113 |
| serious Total, serious adverse events | 2 / 121 | 14 / 113 |
Outcome results
Primary
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
Population: Our protocol excluded those missing primary outcome data from the primary outcome analysis. The primary outcome was adjudicated as 12 months and five patients were lost to follow-up (2 in NB group, 3 in CT-guided Biopsy group). These represent the difference in these denominators for this analysis compared to overall patient numbers. The overall patient numbers (121 an 113) were used as base denominators for all other outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Diagnostic Accuracy | 94 Participants |
| CT-guided Biopsy | Diagnostic Accuracy | 81 Participants |
p-value: 0.00395% CI: [-6.5, 17.2]One-sided two-sample z-test
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Confident Clinical Diagnosis | 96 Participants |
| CT-guided Biopsy | Confident Clinical Diagnosis | 88 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Diagnostic Yield | 96 Participants |
| CT-guided Biopsy | Diagnostic Yield | 88 Participants |
Secondary
Duration of Procedure
Total time required to complete the procedure
Time frame: Up to 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Duration of Procedure | 36 minutes |
| CT-guided Biopsy | Duration of Procedure | 24.5 minutes |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Need for Additional Nodule Biopsy | 16 Participants |
| CT-guided Biopsy | Need for Additional Nodule Biopsy | 15 Participants |
Secondary
Need for Additional Procedure for Staging
Proportion of cases in which a subsequent procedure was performed for staging
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Need for Additional Procedure for Staging | 0 Participants |
| CT-guided Biopsy | Need for Additional Procedure for Staging | 3 Participants |
Secondary
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
Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Need for F-Nav During Navigation Bronchoscopy | 96 Participants |
| CT-guided Biopsy | Need for F-Nav During Navigation Bronchoscopy | 71 Participants |
| Nondiagnostic | Need for F-Nav During Navigation Bronchoscopy | 25 Participants |
Secondary
Need for Hospitalization After Procedure
Proportion of cases with complication necessitating hospitalization after a procedure
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Need for Hospitalization After Procedure | 1 Participants |
| CT-guided Biopsy | Need for Hospitalization After Procedure | 13 Participants |
Secondary
Procedural Factors Associated With Improved Yield (Biopsy Site)
Association of diagnostic yield with biopsy site (nodule location)
Time frame: Up to 12 months
Population: Each trial arm is being split into two groups, whether the lung nodule is in the outer-third zone or middle-third zone. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Biopsy Site) | Nodule is in outer-third zone | 86 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Biopsy Site) | Nodule is in middle-third zone | 10 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Biopsy Site) | Nodule is in outer-third zone | 77 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Biopsy Site) | Nodule is in middle-third zone | 11 Participants |
Secondary
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
Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Number of Biopsies) | TBNA needle passes | 8.0 number of biopsies |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Number of Biopsies) | Forceps TBB pass count | 5.0 number of biopsies |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Number of Biopsies) | TBNA needle passes | 8.0 number of biopsies |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Number of Biopsies) | Forceps TBB pass count | 5.0 number of biopsies |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Number of Biopsies) | TBNA needle passes | 8.0 number of biopsies |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Number of Biopsies) | Forceps TBB pass count | 5.0 number of biopsies |
Secondary
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
Population: Each trial arm is being split into two groups, whether a bronchus sign was present or absent. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) | Presence of a bronchus sign | 37 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) | Without a bronchus sign | 59 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) | Presence of a bronchus sign | 30 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) | Without a bronchus sign | 58 Participants |
Secondary
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
Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Transbronchial biopsy (TBB) using forceps | 76 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | GenCut biopsy tool | 3 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Triple needle brushing | 2 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Transbronchial needle aspiration (TBNA) | 116 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Any specimen cultured | 25 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Peripheral wash via navigation catheter | 31 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Peripheral brushing with standard brush | 22 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Triple needle brushing | 2 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Transbronchial needle aspiration (TBNA) | 93 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Transbronchial biopsy (TBB) using forceps | 64 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Peripheral brushing with standard brush | 17 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | GenCut biopsy tool | 1 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Peripheral wash via navigation catheter | 22 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Any specimen cultured | 15 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | GenCut biopsy tool | 2 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Transbronchial biopsy (TBB) using forceps | 12 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Any specimen cultured | 10 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Peripheral wash via navigation catheter | 9 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Triple needle brushing | 0 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Peripheral brushing with standard brush | 5 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy) | Transbronchial needle aspiration (TBNA) | 23 Participants |
Secondary
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
Population: 16 patients not included: CT performed on the day of the procedure demonstrated regressing nodules in 10 patients and the proceduralist decided to cancel in 6 patients. There were pre-specified exclusion criteria for this outcome measure.~Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : 19 | 75 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : <19 | 6 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : 20 | 12 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : Not used | 4 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | FNA performed | 6 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsies performed | 89 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsy gauge: 18 or 19 | 6 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsy gauge: 20 or 21 | 83 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Any specimen cultured | 8 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsy gauge: 20 or 21 | 74 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : 19 | 64 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | FNA performed | 4 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : Not used | 1 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : <19 | 4 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Any specimen cultured | 8 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsies performed | 78 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsy gauge: 18 or 19 | 4 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : 20 | 9 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsies performed | 11 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : Not used | 3 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | FNA performed | 2 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsy gauge: 20 or 21 | 9 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : 20 | 3 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Core biopsy gauge: 18 or 19 | 2 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Any specimen cultured | 0 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : <19 | 2 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group | Coaxial needle gauge : 19 | 11 Participants |
Secondary
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
Population: Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial REBUS signature: Eccentric | 39 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | REBUS not used during procedure | 13 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial REBUS signature: Could not localize | 47 Participants |
| Navigation Bronchoscopy (NB) With F-Nav | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial Radial Endobronchial Ultrasound (REBUS) signature: Concentric | 20 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial REBUS signature: Could not localize | 32 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | REBUS not used during procedure | 12 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial REBUS signature: Eccentric | 30 Participants |
| CT-guided Biopsy | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial Radial Endobronchial Ultrasound (REBUS) signature: Concentric | 20 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | REBUS not used during procedure | 1 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial Radial Endobronchial Ultrasound (REBUS) signature: Concentric | 0 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial REBUS signature: Could not localize | 15 Participants |
| Nondiagnostic | Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) | Initial REBUS signature: Eccentric | 9 Participants |
Secondary
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
Population: CT-guided biopsy arm has units of mGy\*cm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Radiation Exposure From CT for CT-guided Biopsy | 659 mGy*cm |
Secondary
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
Population: The NB arm has units of mGy\*cm\^2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Radiation Exposure From Fluoroscopy-guided Bronchoscopy | 9800 mGy*cm^2 |
Secondary
Rate of Pneumothorax
Proportion of cases complicated by pneumothorax
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Rate of Pneumothorax | 4 Participants |
| CT-guided Biopsy | Rate of Pneumothorax | 32 Participants |
Secondary
Rate of Pneumothorax Requiring Chest Tube Placement
Proportion of cases complicated by pneumothorax requiring chest tube placement
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Bronchoscopy (NB) With F-Nav | Rate of Pneumothorax Requiring Chest Tube Placement | 1 Participants |
| CT-guided Biopsy | Rate of Pneumothorax Requiring Chest Tube Placement | 9 Participants |