CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Not Applicable

Terminated

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

Interventions: Radiation: Navigation Bronchoscopy
Radiation: Cone beam computed tomography (CBCT)

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
CBCT-GUIDED Navigation Bronchoscopy	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 ALONE	Navigation Bronchoscopy	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
CBCT-GUIDED Navigation Bronchoscopy	Cone beam computed tomography (CBCT)	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.