Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-02 @ 11:51 AM
Study NCT ID:
NCT01077492
Status:
TERMINATED
Last Update Posted:
2012-11-02
First Post:
2010-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-01', 'studyFirstSubmitDate': '2010-02-26', 'studyFirstSubmitQcDate': '2010-02-26', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of VB in determining N2/N3 mediastinal lymph nodes', 'timeFrame': '1 year', 'description': 'Feasibility of virtual bronchoscopy in showing the presence or abscense of N2/N3 mediastinal lymph node (MLN) metastasis with accuracy of 0.6 in puncturing MLN \\> 15 mm (CT images) and accuracy of 0.8 for MLN \\< 15 mm in the second phase of the study.'}], 'secondaryOutcomes': [{'measure': 'Duration of the session within the optimal time window of local anesthesia using lidocaine 1%; comparable to standard routine bronchoscopic procedure on an outpatient basis, i.e. not exceeding 30 minutes.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer', 'mediastinal lymph nodes', 'TBNA', 'staging lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.', 'detailedDescription': 'Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is paramount as the N stage largely determines treatment strategy, prognosis and outcome. Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive alternative is transbronchial needle aspiration (TBNA). This technique is limited however by moderate and operator dependent accuracy. Recently less invasive strategies such as esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA however are required specific expertise, higher equipment and maintenance costs, the need for more assisting personnel and the need for sedation. Advances in computer generated image processing based on available CT and PET images enable (quasi) real-time virtual bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy. Optimizing the traditional TBNA procedure with these modern imaging techniques might be equally accurate and more cost effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings\n* Suspected involvement of mediastinal lymph nodes on CT-PET scan\n* Written informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01077492', 'briefTitle': 'Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer', 'orgStudyIdInfo': {'id': '09/327'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected mediastianl lymph nodes', 'description': 'Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.', 'interventionNames': ['Other: Virtual Bronchoscopy Navigation']}], 'interventions': [{'name': 'Virtual Bronchoscopy Navigation', 'type': 'OTHER', 'description': 'Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.', 'armGroupLabels': ['Suspected mediastianl lymph nodes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Sayed Hashemi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Hans Daniels, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Emiel Comans, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Otto Hoekstra, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Piet Postmus, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Tom Sutedja, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'T.G. Sutedja, MD, PhD', 'oldOrganization': 'VU University Medical Center'}}}}