CBCT-Guided Navigational Bronchoscopy For Lung Nodules

NCT04758403 | Terminated Results DMC FDA Device

• 1 other identifier: 20-580
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Incidence of Procedure-related Complications

  6 months

• Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy.

  6 Months

• Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy.

  6 Months

Study Arms (2)

Navigation Bronchoscopy ALONE

EXPERIMENTAL

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

CBCT-GUIDED Navigation Bronchoscopy

EXPERIMENTAL

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; Radiation: Cone beam computed tomography (CBCT)

Interventions

Navigation Bronchoscopy RADIATION

Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.

Also known as: NB

CBCT-GUIDED Navigation Bronchoscopy; Navigation Bronchoscopy ALONE

Cone beam computed tomography (CBCT) RADIATION

Per Protocol

CBCT-GUIDED Navigation Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Philips Healthcare: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (25)

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  BACKGROUND

Results Point of Contact

• Title: Adnan Majid
• Organization: BIDMC

tsipresearchstaff@bidmc.harvard.edu

617-632-8386

Study Officials

• Adnan Majid, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 17, 2021
• Study Start: March 5, 2021
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)