Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT05739695
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2022-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety profile of each study arm', 'timeFrame': 'At the end of study enrollment', 'description': 'Incidence of complications reported at each study arm procedures'}], 'primaryOutcomes': [{'measure': 'Diagnostic Efficacy of navigational bronchoscopy in each study arm', 'timeFrame': 'At the end of study enrollment', 'description': 'Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm'}], 'secondaryOutcomes': [{'measure': 'Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis', 'timeFrame': 'At the end of study enrollment', 'description': 'Incidence of final diagnoses confirmed by navigational bronchoscopy for bronchoalveolar lavage, brush and transbronchial lung biopsy separately'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['navigation bronchoscopy', 'virtual bronchoscopy navigation', 'radial endobronchial ultrasound', 'BAL', 'TBLB'], 'conditions': ['Lung Cancer', 'Tuberculosis', 'Pneumonia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheral pulmonary lesions (PPLs)\n2. PPL size 5 - 40 mm\n3. Actual chest CT scan (\\<31 days prior to navigation bronchoscopy), collimation 1 mm, pulmonary window, DICOM format\n4. Age \\> 18 years\n5. Signed Informed consent form\n6. Willing and ability to undergone a navigational bronchoscopy\n\nExclusion Criteria:\n\n1. Unability to undergone navigation bronchoscopy for any reason\n2. Any malignant disease during last 36 months\n3. Known central endobronchial lesion of any cause\n4. HIV-infection'}, 'identificationModule': {'nctId': 'NCT05739695', 'briefTitle': 'A Trial of Radial EBUS Versus VBN for the Peripheral Pulmonary Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Central TB Research Institute'}, 'officialTitle': 'Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions', 'orgStudyIdInfo': {'id': 'VBN-REBUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VBN', 'description': 'Virtual bronchoscopy', 'interventionNames': ['Diagnostic Test: Virtual bronchoscopy navigation']}, {'type': 'EXPERIMENTAL', 'label': 'VBN+rEBUS', 'description': 'Combination of VBN and radial EBUS', 'interventionNames': ['Diagnostic Test: Virtual bronchoscopy navigation', 'Diagnostic Test: radial EBUS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rEBUS', 'description': 'Radial EBUS as a gold standard', 'interventionNames': ['Diagnostic Test: radial EBUS']}], 'interventions': [{'name': 'Virtual bronchoscopy navigation', 'type': 'DIAGNOSTIC_TEST', 'description': 'It is planned to use VBN as the only navigation technique to compare it with rEBUS', 'armGroupLabels': ['VBN', 'VBN+rEBUS']}, {'name': 'radial EBUS', 'type': 'DIAGNOSTIC_TEST', 'description': 'It is planned to use rEBUS as the only navigation technique to compare it with VBN', 'armGroupLabels': ['VBN+rEBUS', 'rEBUS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chelyabinsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Konstantin Kulaev, Md PhD', 'role': 'CONTACT'}], 'facility': 'Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Kurgan', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yulia Verkhodlib, MD', 'role': 'CONTACT'}], 'facility': 'Kurgan Regional Oncological Dispensary', 'geoPoint': {'lat': 55.44905, 'lon': 65.34344}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ilya Sivokozov, MD PhD', 'role': 'CONTACT', 'email': 'sivokozov@bronchology.ru'}, {'name': 'Irina Shabalina, MD PhD', 'role': 'CONTACT'}, {'name': 'Yana Chesalina, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Central TB Research Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander Vodoleev, MD PhD', 'role': 'CONTACT'}], 'facility': 'P. Hertsen Moscow Oncology Research Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Rostov-on-Don', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vadislav Legostaev, MD PhD', 'role': 'CONTACT'}], 'facility': 'National Medical Research Centre for Oncology', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Tomsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Natalya Li, MD', 'role': 'CONTACT'}], 'facility': 'Tomsk Regional Oncological Dispensary', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'centralContacts': [{'name': 'Ilya Sivokozov, MD PhD', 'role': 'CONTACT', 'email': 'sivokozov@bronchology.ru', 'phone': '+79670457905'}], 'overallOfficials': [{'name': 'Ilya Sivokozov, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Central TB Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ilya Sivokozov', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Respiratory Endoscopy Department', 'investigatorFullName': 'Ilya Sivokozov', 'investigatorAffiliation': 'Central TB Research Institute'}}}}