Comparing navigation techniques for diagnosing lung lesions
Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions
NA · Central TB Research Institute · NCT05739695
This study is testing which of three different methods for guiding lung examinations works best for diagnosing lung problems like cancer, tuberculosis, and pneumonia in patients with newly found lung lesions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central TB Research Institute (other) |
| Locations | 6 sites (Chelyabinsk and 5 other locations) |
| Trial ID | NCT05739695 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare three different navigation techniques used in bronchoscopic investigations for peripheral pulmonary lesions: virtual bronchoscopy (VBN), radial endobronchial ultrasound (EBUS), and a combination of both. Approximately 300 patients with newly diagnosed, unverified peripheral pulmonary lesions will be enrolled across nine centers in Russia. Participants will be randomly assigned to one of the three navigation technique groups, and the study will analyze the diagnostic efficacy and safety of each method. The goal is to determine which technique provides the best outcomes for early detection of lung cancer, tuberculosis, and pneumonia.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed solitary or multiple peripheral pulmonary lesions sized between 5 to 40 mm.
Not a fit: Patients unable to undergo navigation bronchoscopy or those with a history of malignant disease in the last 36 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy and safety of diagnosing lung conditions, leading to earlier treatment for patients.
How similar studies have performed: Other studies have explored similar navigation techniques, but this specific comparison of VBN and radial EBUS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chelyabinsk and 5 other locations
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine — Chelyabinsk, Russian Federation (RECRUITING)
- Kurgan Regional Oncological Dispensary — Kurgan, Russian Federation (RECRUITING)
- Central TB Research Institute — Moscow, Russian Federation (RECRUITING)
- P. Hertsen Moscow Oncology Research Institute — Moscow, Russian Federation (RECRUITING)
- National Medical Research Centre for Oncology — Rostov-on-Don, Russian Federation (RECRUITING)
- Tomsk Regional Oncological Dispensary — Tomsk, Russian Federation (RECRUITING)
Study contacts
- Study coordinator: Ilya Sivokozov, MD PhD
- Email: sivokozov@bronchology.ru
- Phone: +79670457905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancer, Tuberculosis, Pneumonia, navigation bronchoscopy, virtual bronchoscopy navigation, radial endobronchial ultrasound, BAL, TBLB