Localization of Peripheral Pulmonary Lesions: A Pilot Study

NCT03536026 | Withdrawn Phase 1 DMC FDA Device

• 1 other identifier: 201711034
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.

Conditions

Peripheral Lung Lesions

Outcome Measures

Primary Outcomes (1)

• Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound

  At the time of bronchoscopy (day 1)

Secondary Outcomes (4)

• Rate of lesion localization using a conventional chest CT as a reference only

  At the time of bronchoscopy (day 1)

• Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only)

  At the time of bronchoscopy (day 1)

• Time to localization of peripheral pulmonary lesions

  At the time of bronchoscopy (day 1)

• Diagnostic yield of procedures

  At the time of bronchoscopy (day 1)

Study Arms (1)

Bronchoscopic evaluation and biopsy

EXPERIMENTAL

-Bronchoscopy will be performed by pulmonary and/or critical care fellows who have performed fewer than 10 bronchoscopies (inexperienced bronchoscopists) under direct supervision by an attending Interventional Pulmonologist. The inexperienced bronchoscopist will attempt to navigate to the targeted peripheral pulmonary lesion without virtual bronchoscopic navigation, using only standard axial CT images as a reference. The attending physician will directly observe, but will provide no guidance during this period, which will last no longer than 10 minutes. If the lesion is located and confirmed with radial probe endobronchial ultrasound prior to 10 minutes, biopsies will be performed as per routine clinical practice. If the 10 minute time period elapses prior to localization of the peripheral pulmonary lesion, virtual bronchoscopic navigation will be used.

Procedure: Conventional bronchoscopy; Device: VIDA Pulmonary Workstation 2; Procedure: Biopsy

Interventions

Conventional bronchoscopy PROCEDURE

-Standard of care

Bronchoscopic evaluation and biopsy

VIDA Pulmonary Workstation 2 DEVICE

-Virtual bronchoscopic navigation system

Bronchoscopic evaluation and biopsy

Biopsy PROCEDURE

-Standard of care

Bronchoscopic evaluation and biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
• Are at least 18 years old
• Are able to provide informed consent
• Have CT scans within 30 days suitable for use with the virtual bronchoscopic system

You may not qualify if:

• Patients who refuse to participate
• Are less than 18 years of age
• Are pregnant
• Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
• Are unable to provide informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexander Chen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: April 30, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share