CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Beth Israel Lahey Health

Status: Terminated

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

Treatments: Radiation: Navigation Bronchoscopy; Radiation: Cone beam computed tomography (CBCT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04758403

20-580

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Navigation Bronchoscopy ALONE

Experimental group

Description:

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

Treatment:

Radiation: Navigation Bronchoscopy

CBCT-GUIDED Navigation Bronchoscopy

Experimental group

Description:

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

Treatment:

Radiation: Cone beam computed tomography (CBCT)

Radiation: Navigation Bronchoscopy