Clinical trial NCT04758403: CBCT-Guided Navigational Bronchoscopy For Lung Nodules
Official title: Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Pulmonary Nodules
Lung; Node
Cone Beam Computed Tomography
Guided Navigation Bronchoscopy
Keywords: Peripheral Pulmonary Nodules
Lung; Node
Cone Beam Computed Tomography
Guided Navigation Bronchoscopy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: Dana-Farber Cancer Institute
First posted: 2021-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Diagnostic Yield
timeFrame: 6 months
Secondary outcomes:
measure: Overall Incidence of Procedure-related Complications
timeFrame: 6 months
measure: Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy.
timeFrame: 6 Months
measure: Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Adnan Majid, MD
role: PRINCIPAL_INVESTIGATOR
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