Lung CancerNCT05739695
A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions
A study testing Virtual bronchoscopy navigation and radial EBUS in people with Lung Cancer and Tuberculosis, run by Ilya Sivokozov at 6 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Tuberculosis, Pneumonia
- What is being tested?
- Virtual bronchoscopy navigation and radial EBUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 6 sitesRussia
- Study dates
- 1 Feb 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unability to undergone navigation bronchoscopy for any reason
- Any malignant disease during last 36 months
- Known central endobronchial lesion of any cause
- HIV-infection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Chelyabinsk
Kurgan Regional Oncological Dispensary
Kurgan
Central TB Research Institute
Moscow
P. Hertsen Moscow Oncology Research Institute
Moscow
National Medical Research Centre for Oncology
Rostov-on-Don
Tomsk Regional Oncological Dispensary
Tomsk
About this study
Official title: Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions
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.
Read the 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.
- Conditions
- Lung Cancer, Tuberculosis, Pneumonia
- Being tested
- Virtual bronchoscopy navigation, radial EBUS
- Keywords
- navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, BAL, TBLB
- Medical subject headings
- Lung Neoplasms, Tuberculosis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual bronchoscopy navigationDiagnostic test
It is planned to use VBN as the only navigation technique to compare it with rEBUS
radial EBUSDiagnostic test
It is planned to use rEBUS as the only navigation technique to compare it with VBN
| Study group | Role | What they receive |
|---|---|---|
| VBN | Experimental | Virtual bronchoscopy Receives: Diagnostic Test: Virtual bronchoscopy navigation |
| VBN+rEBUS | Experimental | Combination of VBN and radial EBUS Receives: Diagnostic Test: Virtual bronchoscopy navigation; Diagnostic Test: radial EBUS |
| rEBUS | Active comparator | Radial EBUS as a gold standard Receives: Diagnostic Test: radial EBUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Efficacy of navigational bronchoscopy in each study arm
Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm
Measured: At the end of study enrollment
Secondary outcomes (1)
Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis
Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately
Measured: At the end of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Feb 2022
- Primary completion1 Jan 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilya Sivokozov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilya Sivokozov, Central TB Research Institute
- Investigators
- Ilya Sivokozov, MD PhD, Study chair, Central TB Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739695
- Sponsor's protocol ID
- VBN-REBUS
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT05739695
- Acronym / sponsor ID
- VBN-REBUS
- Conditions
- Lung Cancer, Tuberculosis, Pneumonia
- Keywords
- navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, BAL, TBLB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ilya SivokozovUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VBN | Experimental | Diagnostic Test: Virtual bronchoscopy navigationVirtual bronchoscopy |
| VBN+rEBUS | Experimental | Diagnostic Test: Virtual bronchoscopy navigation, Diagnostic Test: radial EBUSCombination of VBN and radial EBUS |
| rEBUS | Active comparator | Diagnostic Test: radial EBUSRadial EBUS as a gold standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Unability to undergone navigation bronchoscopy for any reason
- Any malignant disease during last 36 months
- Known central endobronchial lesion of any cause
- HIV-infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual bronchoscopy navigationIt is planned to use VBN as the only navigation technique to compare it with rEBUS | Diagnostic test | VBN, VBN+rEBUS |
| radial EBUSIt is planned to use rEBUS as the only navigation technique to compare it with VBN | Diagnostic test | VBN+rEBUS, rEBUS |
Primary outcome
Diagnostic Efficacy of navigational bronchoscopy in each study arm
Time frame: At the end of study enrollment
Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm
1 secondary outcome
Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis
Time frame: At the end of study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Sivokozov, MD PhD study chair
Central TB Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual bronchoscopy navigation and radial EBUS in people with Lung Cancer and Tuberculosis, run by Ilya Sivokozov at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Efficacy of navigational bronchoscopy in each study arm (time frame: At the end of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.