NCT05739695

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

February 4, 2022

Last Update Submit

February 5, 2024

Conditions

Lung CancerTuberculosisPneumonia

Keywords

navigation bronchoscopyvirtual bronchoscopy navigationradial endobronchial ultrasoundBALTBLB

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Efficacy of navigational bronchoscopy in each study arm

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

    At the end of study enrollment

Secondary Outcomes (1)

  • Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis

    At the end of study enrollment

Other Outcomes (1)

  • Safety profile of each study arm

    At the end of study enrollment

Study Arms (3)

VBN

EXPERIMENTAL

Virtual bronchoscopy

Diagnostic Test: Virtual bronchoscopy navigation

VBN+rEBUS

EXPERIMENTAL

Combination of VBN and radial EBUS

Diagnostic Test: Virtual bronchoscopy navigationDiagnostic Test: radial EBUS

rEBUS

ACTIVE COMPARATOR

Radial EBUS as a gold standard

Diagnostic Test: radial EBUS

Interventions

Virtual bronchoscopy navigationDIAGNOSTIC_TEST

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

VBNVBN+rEBUS
radial EBUSDIAGNOSTIC_TEST

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

VBN+rEBUSrEBUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unability to undergone navigation bronchoscopy for any reason
  • Any malignant disease during last 36 months
  • Known central endobronchial lesion of any cause
  • HIV-infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

Chelyabinsk, Russia

RECRUITING

Kurgan Regional Oncological Dispensary

Kurgan, Russia

RECRUITING

Central TB Research Institute

Moscow, Russia

RECRUITING

P. Hertsen Moscow Oncology Research Institute

Moscow, Russia

RECRUITING

National Medical Research Centre for Oncology

Rostov-on-Don, Russia

RECRUITING

Tomsk Regional Oncological Dispensary

Tomsk, Russia

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsTuberculosisPneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract Infections

Study Officials

  • Ilya Sivokozov, MD PhD

    Central TB Research Institute

    STUDY CHAIR

Central Study Contacts

Ilya Sivokozov, MD PhD

CONTACT

+79670457905sivokozov@bronchology.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Respiratory Endoscopy Department

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 22, 2023

Study Start

February 1, 2022

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(6)