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

• Sponsor: Ilya Sivokozov (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05739695
• Collaborator: (none)
• Enrollment: 300
• Locations: 6
• Arms: 3
• Anticipated Duration (Months): 24.9
• Patients Per Site: 50
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Tuberculosis; Pneumonia	Diagnostic Test: Virtual bronchoscopy navigation; Diagnostic Test: radial EBUS	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions
• Actual Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VBN Virtual bronchoscopy	Diagnostic Test: Virtual bronchoscopy navigation; It is planned to use VBN as the only navigation technique to compare it with rEBUS
Experimental: VBN+rEBUS Combination of VBN and radial EBUS	Diagnostic Test: Virtual bronchoscopy navigation; It is planned to use VBN as the only navigation technique to compare it with rEBUS; Diagnostic Test: radial EBUS; It is planned to use rEBUS as the only navigation technique to compare it with VBN
Active Comparator: rEBUS Radial EBUS as a gold standard	Diagnostic Test: radial EBUS; It is planned to use rEBUS as the only navigation technique to compare it with VBN

Outcome Measures

Primary Outcome Measures

1. Diagnostic Efficacy of navigational bronchoscopy in each study arm [At the end of study enrollment]

   Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm

Secondary Outcome Measures

1. Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis [At the end of study enrollment]

   Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately

Other Outcome Measures

1. Safety profile of each study arm [At the end of study enrollment]

   Incidence of complications reported at each study arm procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheral pulmonary lesions (PPLs)

2. PPL size 5 - 40 mm

3. Actual chest CT scan (<31 days prior to navigation bronchoscopy), collimation 1 mm, pulmonary window, DICOM format

4. Age > 18 years

5. Signed Informed consent form

6. Willing and ability to undergone a navigational bronchoscopy

Exclusion Criteria:

1. Unability to undergone navigation bronchoscopy for any reason

2. Any malignant disease during last 36 months

3. Known central endobronchial lesion of any cause

4. HIV-infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine	Chelyabinsk		Russian Federation
2	Kurgan Regional Oncological Dispensary	Kurgan		Russian Federation
3	Central TB Research Institute	Moscow		Russian Federation
4	P. Hertsen Moscow Oncology Research Institute	Moscow		Russian Federation
5	National Medical Research Centre for Oncology	Rostov-on-Don		Russian Federation
6	Tomsk Regional Oncological Dispensary	Tomsk		Russian Federation

Sponsors and Collaborators

• Ilya Sivokozov

Investigators

• Study Chair: Ilya Sivokozov, MD PhD, Central TB Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilya Sivokozov, Head of Respiratory Endoscopy Department, Central TB Research Institute
• ClinicalTrials.gov Identifier: NCT05739695
• Other Study ID Numbers: VBN-REBUS
• First Posted: Feb 22, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ilya Sivokozov, Head of Respiratory Endoscopy Department, Central TB Research Institute: navigation bronchoscopy; virtual bronchoscopy navigation; radial endobronchial ultrasound; BAL; TBLB
• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Feb 22, 2023