Peripheral Pulmonary Nodules, Lung; Node, Cone Beam Computed Tomography, Guided Navigation Bronchoscopy
Conditions
Keywords
Peripheral Pulmonary Nodules, Lung; Node, Cone Beam Computed Tomography, Guided Navigation Bronchoscopy
Brief summary
The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.
Detailed description
This clinical trial examines the effectiveness of a treatment comparing it to another known treatment. The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease. The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease. This research study involves a screening period, a procedure and follow up visits. The names of the study interventions involved in this study are: * Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB) * Navigation bronchoscopy alone Participants will receive the study procedure and will be followed for up to 6 months. It is expected that about 136 people will take part in this research study.
Interventions
RADIATIONNavigation Bronchoscopy
Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
RADIATIONCone beam computed tomography (CBCT)
Per Protocol
Sponsors
Philips Healthcare
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical 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
Yes
Inclusion criteria
* Participants ≥18 years old. * Participants with lesions having an intermediate pre-test probability of malignancy (pCA, 0.05 to 0.65) as determined by Swensen-Mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist. * Participants with higher risk lesions (pCA \> 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery. * Participants are willing and able to provide informed consent.
Exclusion criteria
* The participant is pregnant as confirmed by urine or serum pregnancy testing. * There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. The participant would not go on for a CT guided TTNA). * Lacked fitness according to physician judgement to undergo bronchoscopy. * Contraindication for temporary interruption of the use of anticoagulant therapy. * Uncontrolled or irreversible coagulopathy. * Known allergy for lidocaine. * Uncontrolled pulmonary hypertension. * Recent (\< 4 weeks) and/or uncontrolled cardiac disease. * Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe). * ASA classification ≥ 4. * COVID-19 positive participant at the time of procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Diagnostic Yield | 6 months | The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Incidence of Procedure-related Complications | 6 months | To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy. |
| Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy. | 6 Months | To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy. |
| Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy. | 6 Months | To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Navigation Bronchoscopy ALONE This research study involves a screening period, a procedure and follow up visits
* Procedure Visit Navigation Bronchoscopy Alone
* Follow-Up Visits at Week 1, 4 and 12
Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice. | 10 |
| CBCT-GUIDED Navigation Bronchoscopy This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules
-Follow-Up Visits at Week 1, 4 and 12
Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
Cone beam computed tomography (CBCT): Per Protocol | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | CBCT-GUIDED Navigation Bronchoscopy | Total | Navigation Bronchoscopy ALONE |
|---|---|---|---|
| Age, Continuous | 79 years | 78 years | 76 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 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 | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Overall Diagnostic Yield
The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.
Time frame: 6 months
Population: Enrolled before trial termination but no data were collected.
Secondary
Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy.
To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.
Time frame: 6 Months
Population: Enrolled before trial termination but no data were collected.
Secondary
Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy.
To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.
Time frame: 6 Months
Population: Enrolled before trial termination but no data were collected.
Secondary
Overall Incidence of Procedure-related Complications
To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.
Time frame: 6 months
Population: Enrolled before trial termination but no data were collected.