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Trial Title:
A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions
NCT ID:
NCT05739695
Condition:
Lung Cancer
Tuberculosis
Pneumonia
Conditions: Official terms:
Tuberculosis
Conditions: Keywords:
navigation bronchoscopy
virtual bronchoscopy navigation
radial endobronchial ultrasound
BAL
TBLB
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Virtual bronchoscopy navigation
Description:
It is planned to use VBN as the only navigation technique to compare it with rEBUS
Arm group label:
VBN
Arm group label:
VBN+rEBUS
Intervention type:
Diagnostic Test
Intervention name:
radial EBUS
Description:
It is planned to use rEBUS as the only navigation technique to compare it with VBN
Arm group label:
VBN+rEBUS
Arm group label:
rEBUS
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Konstantin Kulaev, Md PhD
Facility:
Name:
Kurgan Regional Oncological Dispensary
Address:
City:
Kurgan
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Yulia Verkhodlib, MD
Facility:
Name:
Central TB Research Institute
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ilya Sivokozov, MD PhD
Email:
sivokozov@bronchology.ru
Contact backup:
Last name:
Irina Shabalina, MD PhD
Investigator:
Last name:
Yana Chesalina, MD
Email:
Sub-Investigator
Facility:
Name:
P. Hertsen Moscow Oncology Research Institute
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Alexander Vodoleev, MD PhD
Facility:
Name:
National Medical Research Centre for Oncology
Address:
City:
Rostov-on-Don
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vadislav Legostaev, MD PhD
Facility:
Name:
Tomsk Regional Oncological Dispensary
Address:
City:
Tomsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Natalya Li, MD
Start date:
February 1, 2022
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Ilya Sivokozov
Agency class:
Other
Source:
Central TB Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739695
