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

NCT ID: NCT05739695

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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

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Lung Cancer Tuberculosis Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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VBN

Virtual bronchoscopy

Group Type EXPERIMENTAL

Virtual bronchoscopy navigation

Intervention Type DIAGNOSTIC_TEST

It is planned to use VBN as the only navigation technique to compare it with rEBUS

VBN+rEBUS

Combination of VBN and radial EBUS

Group Type EXPERIMENTAL

Virtual bronchoscopy navigation

Intervention Type DIAGNOSTIC_TEST

It is planned to use VBN as the only navigation technique to compare it with rEBUS

radial EBUS

Intervention Type DIAGNOSTIC_TEST

It is planned to use rEBUS as the only navigation technique to compare it with VBN

rEBUS

Radial EBUS as a gold standard

Group Type ACTIVE_COMPARATOR

radial EBUS

Intervention Type DIAGNOSTIC_TEST

It is planned to use rEBUS as the only navigation technique to compare it with VBN

Interventions

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Virtual bronchoscopy navigation

It is planned to use VBN as the only navigation technique to compare it with rEBUS

Intervention Type DIAGNOSTIC_TEST

radial EBUS

It is planned to use rEBUS as the only navigation technique to compare it with VBN

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ilya Sivokozov

OTHER

Sponsor Role lead

Responsible Party

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Ilya Sivokozov

Head of Respiratory Endoscopy Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ilya Sivokozov, MD PhD

Role: STUDY_CHAIR

Central TB Research Institute

Locations

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Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, , Russia

Site Status RECRUITING

Kurgan Regional Oncological Dispensary

Kurgan, , Russia

Site Status RECRUITING

Central TB Research Institute

Moscow, , Russia

Site Status RECRUITING

P. Hertsen Moscow Oncology Research Institute

Moscow, , Russia

Site Status RECRUITING

National Medical Research Centre for Oncology

Rostov-on-Don, , Russia

Site Status RECRUITING

Tomsk Regional Oncological Dispensary

Tomsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Ilya Sivokozov, MD PhD

Role: CONTACT

+79670457905

Facility Contacts

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Konstantin Kulaev, Md PhD

Role: primary

Yulia Verkhodlib, MD

Role: primary

Ilya Sivokozov, MD PhD

Role: primary

Irina Shabalina, MD PhD

Role: backup

Alexander Vodoleev, MD PhD

Role: primary

Vadislav Legostaev, MD PhD

Role: primary

Natalya Li, MD

Role: primary

Other Identifiers

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VBN-REBUS

Identifier Type: -

Identifier Source: org_study_id

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