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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739695
• Other study ID #: VBN-REBUS
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Central TB Research Institute
• Contact: Ilya Sivokozov, MD PhD
• Phone: +79670457905
• Email: sivokozov[@]bronchology.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Pneumonia
• Tuberculosis

Intervention

Diagnostic Test:
• Virtual bronchoscopy navigation
It is planned to use VBN as the only navigation technique to compare it with rEBUS
• radial EBUS
It is planned to use rEBUS as the only navigation technique to compare it with VBN

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine	Chelyabinsk
Russian Federation	Kurgan Regional Oncological Dispensary	Kurgan
Russian Federation	Central TB Research Institute	Moscow
Russian Federation	P. Hertsen Moscow Oncology Research Institute	Moscow
Russian Federation	National Medical Research Centre for Oncology	Rostov-on-Don
Russian Federation	Tomsk Regional Oncological Dispensary	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Ilya Sivokozov

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety profile of each study arm	Incidence of complications reported at each study arm procedures	At the end of study enrollment
Primary	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	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	At the end of study enrollment