A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions

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Description

Peripheral pulmonary lesions are of growing importance in respiratory field. Early detection of lung cancer, tuberculosis and other diseases often needs a bronchoscopic investigation with different types of navigation. Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy (VBN), radial endobronchial ultrasound (EBUS) and combination of both techniques.

Study Overview

Start Date
February 1, 2022
Completion Date
March 1, 2025
Enrollment
300
Date Posted
February 22, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Chelyabinsk, Russian Federation

Kurgan Regional Oncological Dispensary
Kurgan, Russian Federation

Central TB Research Institute
Moscow, Russian Federation

P. Hertsen Moscow Oncology Research Institute
Moscow, Russian Federation

National Medical Research Centre for Oncology
Rostov-on-Don, Russian Federation

Tomsk Regional Oncological Dispensary
Tomsk, Russian Federation

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheral pulmonary lesions (PPLs)
PPL size 5 - 40 mm
Actual chest CT scan (<31 days prior to navigation bronchoscopy), collimation 1 mm, pulmonary window, DICOM format
Age > 18 years
Signed Informed consent form
Willing and ability to undergone a navigational bronchoscopy

Exclusion Criteria:

Unability to undergone navigation bronchoscopy for any reason
Any malignant disease during last 36 months
Known central endobronchial lesion of any cause
HIV-infection

Study Contact Info

Study Contact Name
Ilya Sivokozov, MD PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy, radial EBUS and combination of both techniques. Around 300 patients with incidentally detected peripheral pulmonary lesions will be enrolled in 9 centers among Russia. All patients after obtaining an informed consent will be randomized in 1:1:1 fashion to three study groups depending on type of navigation technique used. All patients will undergone navigational bronchoscopy with rEBUS (group A), VBN (group B) and rEBUS+VBN (group C), data on diagnostic efficacy and safety of each modality of navigation will be analyzed.
NCTid (if applicable)
NCT05739695