Due to changes in technology (EMN technology replaced by robotic platform) the study was terminated

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.

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.

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.

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication

Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

2 years