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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
RECRUITING
Chelyabinsk
Kurgan Regional Oncological Dispensary
RECRUITING
Kurgan
Central TB Research Institute
RECRUITING
Moscow
P. Hertsen Moscow Oncology Research Institute
RECRUITING
Moscow
National Medical Research Centre for Oncology
RECRUITING
Rostov-on-don
Tomsk Regional Oncological Dispensary
RECRUITING
Tomsk
Contact Information
Primary
Ilya Sivokozov, MD PhD
sivokozov@bronchology.ru
+79670457905
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 300
Treatments
Experimental: VBN
Virtual bronchoscopy
Experimental: VBN+rEBUS
Combination of VBN and radial EBUS
Active_comparator: rEBUS
Radial EBUS as a gold standard
Related Therapeutic Areas
Sponsors
Leads: Ilya Sivokozov

This content was sourced from clinicaltrials.gov