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

Primary Purpose

Lung Cancer, Tuberculosis, Pneumonia

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Virtual bronchoscopy navigation

radial EBUS

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, BAL, TBLB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chelyabinsk Regional Clinical Center of Oncology and Nuclear MedicineRecruiting
Kurgan Regional Oncological DispensaryRecruiting
Central TB Research InstituteRecruiting
P. Hertsen Moscow Oncology Research InstituteRecruiting
National Medical Research Centre for OncologyRecruiting
Tomsk Regional Oncological DispensaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

VBN

VBN+rEBUS

rEBUS

Arm Description

Virtual bronchoscopy

Combination of VBN and radial EBUS

Radial EBUS as a gold standard

Outcomes

Primary Outcome Measures

Diagnostic Efficacy of navigational bronchoscopy in each study arm

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05739695

First Posted

February 4, 2022

Last Updated

February 13, 2023

Sponsor

Ilya Sivokozov

1. Study Identification

Unique Protocol Identification Number

NCT05739695

Brief Title

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

Official Title

Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ilya Sivokozov

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Tuberculosis, Pneumonia

Keywords

navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, BAL, TBLB

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VBN

Arm Type

Experimental

Arm Description

Virtual bronchoscopy

Arm Title

VBN+rEBUS

Arm Type

Experimental

Arm Description

Combination of VBN and radial EBUS

Arm Title

rEBUS

Arm Type

Active Comparator

Arm Description

Radial EBUS as a gold standard

Intervention Type

Diagnostic Test

Intervention Name(s)

Virtual bronchoscopy navigation

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

radial EBUS

Intervention Description

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

Primary Outcome Measure Information:

Title

Diagnostic Efficacy of navigational bronchoscopy in each study arm

Description

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

Time Frame

At the end of study enrollment

Secondary Outcome Measure Information:

Title

Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis

Description

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

Time Frame

At the end of study enrollment

Other Pre-specified Outcome Measures:

Title

Safety profile of each study arm

Description

Incidence of complications reported at each study arm procedures

Time Frame

At the end of study enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ilya Sivokozov, MD PhD

Phone

+79670457905

sivokozov@bronchology.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilya Sivokozov, MD PhD

Organizational Affiliation

Central TB Research Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

City

Chelyabinsk

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Konstantin Kulaev, Md PhD

Facility Name

Kurgan Regional Oncological Dispensary

City

Kurgan

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yulia Verkhodlib, MD

Facility Name

Central TB Research Institute

City

Moscow

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ilya Sivokozov, MD PhD

sivokozov@bronchology.ru

First Name & Middle Initial & Last Name & Degree

Irina Shabalina, MD PhD

First Name & Middle Initial & Last Name & Degree

Yana Chesalina, MD

Facility Name

P. Hertsen Moscow Oncology Research Institute

City

Moscow

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Vodoleev, MD PhD

Facility Name

National Medical Research Centre for Oncology

City

Rostov-on-Don

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vadislav Legostaev, MD PhD

Facility Name

Tomsk Regional Oncological Dispensary

City

Tomsk

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natalya Li, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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