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

February 5, 2024 updated by: Ilya Sivokozov

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
        • Contact:
          • Konstantin Kulaev, Md PhD
      • Kurgan, Russian Federation
        • Recruiting
        • Kurgan Regional Oncological Dispensary
        • Contact:
          • Yulia Verkhodlib, MD
      • Moscow, Russian Federation
        • Recruiting
        • Central TB Research Institute
        • Contact:
        • Contact:
          • Irina Shabalina, MD PhD
        • Sub-Investigator:
          • Yana Chesalina, MD
      • Moscow, Russian Federation
        • Recruiting
        • P. Hertsen Moscow Oncology Research Institute
        • Contact:
          • Alexander Vodoleev, MD PhD
      • Rostov-on-Don, Russian Federation
        • Recruiting
        • National Medical Research Centre for Oncology
        • Contact:
          • Vadislav Legostaev, MD PhD
      • Tomsk, Russian Federation
        • Recruiting
        • Tomsk Regional Oncological Dispensary
        • Contact:
          • Natalya Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis
Time Frame: At the end of study enrollment
Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately
At the end of study enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety profile of each study arm
Time Frame: At the end of study enrollment
Incidence of complications reported at each study arm procedures
At the end of study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilya Sivokozov

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBN-REBUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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