Localization of Peripheral Pulmonary Lesions: A Pilot Study

Peripheral Lung Lesions Clinical Trial

Official title:

Localization of Peripheral Pulmonary Lesions: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03536026
• Other study ID #: 201711034
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 30, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: December 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Peripheral Lung Lesions

Intervention

Procedure:
• Conventional bronchoscopy
-Standard of care

Device:
• VIDA Pulmonary Workstation 2
-Virtual bronchoscopic navigation system

Procedure:
• Biopsy
-Standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound		At the time of bronchoscopy (day 1)
Secondary	Rate of lesion localization using a conventional chest CT as a reference only		At the time of bronchoscopy (day 1)
Secondary	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)
Secondary	Time to localization of peripheral pulmonary lesions		At the time of bronchoscopy (day 1)
Secondary	Diagnostic yield of procedures	-Diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive.	At the time of bronchoscopy (day 1)

External Links

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