CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial

Conditions
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Peripheral Pulmonary Nodules, Lung; Node, Cone Beam Computed Tomography, Guided Navigation Bronchoscopy

Intervention / Treatment
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* Radiation: Navigation Bronchoscopy
* Radiation: Cone beam computed tomography (CBCT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation Bronchoscopy ALONE<br>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 | Radiation: Navigation Bronchoscopy<br>* Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.<br>* Other names: NB;|
| Experimental: CBCT-GUIDED Navigation Bronchoscopy<br>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 | Radiation: Navigation Bronchoscopy<br>* Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.<br>* Other names: NB;Radiation: Cone beam computed tomography (CBCT)<br>* Per Protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of procedure-related complications | To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy. | 6 months | 
| 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. | 6 Months | 
| 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. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Pulmonary Nodules, Lung; Node, Cone Beam Computed Tomography, Guided Navigation Bronchoscopy