Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-04 @ 5:02 AM
Study NCT ID:
NCT04250194
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fabien.maldonado@vumc.org', 'phone': '615-322-2386', 'title': 'Dr. Fabien Maldonado', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 4, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 19, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5'}, {'term': 'Hemorrhage requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5'}], 'seriousEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'absolute difference in percentage points', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '17.2', 'pValueComment': 'The threshold for statistical significance was p = 0.05. The p value was not adjusted for multiple comparisons.', 'estimateComment': 'Difference in diagnostic accuracy = navigational bronchoscopy % - transthoracic biopsy %', 'statisticalMethod': 'One-sided two-sample z-test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority margin was 10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following:\n\n* Malignant, OR\n* Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR\n* Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND\n* Absence of malignancy (true negative) through 1-year CT follow-up, defined as:\n\n * The nodule markedly regresses or resolves on follow-up imaging, OR\n * A persistent nodule has not been diagnosed as malignant, AND\n * No plans for repeat invasive diagnostic procedures through 12 months follow-up.\n\nNormal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Our protocol excluded those missing primary outcome data from the primary outcome analysis. The primary outcome was adjudicated as 12 months and five patients were lost to follow-up (2 in NB group, 3 in CT-guided Biopsy group). These represent the difference in these denominators for this analysis compared to overall patient numbers. The overall patient numbers (121 an 113) were used as base denominators for all other outcomes.'}, {'type': 'SECONDARY', 'title': 'Diagnostic Yield', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Pneumothorax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases complicated by pneumothorax', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Pneumothorax Requiring Chest Tube Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases complicated by pneumothorax requiring chest tube placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Hospitalization After Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases with complication necessitating hospitalization after a procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '47.5'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months', 'description': 'Total time required to complete the procedure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Factors Associated With Improved Yield (Type of Biopsy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'Patients included are those that received the navigational bronchoscopy intervention'}, {'id': 'OG001', 'title': 'Diagnostic', 'description': 'Patients that received a diagnostic result from the navigational bronchoscopy intervention'}, {'id': 'OG002', 'title': 'Nondiagnostic', 'description': 'Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention'}], 'classes': [{'title': 'Transbronchial needle aspiration (TBNA)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Transbronchial biopsy (TBB) using forceps', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Peripheral brushing with standard brush', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Triple needle brushing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'GenCut biopsy tool', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Peripheral wash via navigation catheter', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Any specimen cultured', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Procedural Factors Associated With Improved Yield (Number of Biopsies)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'Patients included are those that received the navigational bronchoscopy intervention'}, {'id': 'OG001', 'title': 'Diagnostic', 'description': 'Patients that received a diagnostic result from the navigational bronchoscopy intervention'}, {'id': 'OG002', 'title': 'Nondiagnostic', 'description': 'Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention'}], 'classes': [{'title': 'TBNA needle passes', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '8.2'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '8.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '10.0'}]}]}, {'title': 'Forceps TBB pass count', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.', 'unitOfMeasure': 'number of biopsies', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'Patients included are those that received the navigational bronchoscopy intervention'}, {'id': 'OG001', 'title': 'Diagnostic', 'description': 'Patients that received a diagnostic result from the navigational bronchoscopy intervention'}, {'id': 'OG002', 'title': 'Nondiagnostic', 'description': 'Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention'}], 'classes': [{'categories': [{'title': 'Initial Radial Endobronchial Ultrasound (REBUS) signature: Concentric', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Initial REBUS signature: Eccentric', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': 'Initial REBUS signature: Could not localize', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'title': 'REBUS not used during procedure', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'title': 'Presence of a bronchus sign', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Without a bronchus sign', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with presence of a bronchus sign', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each trial arm is being split into two groups, whether a bronchus sign was present or absent. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.'}, {'type': 'SECONDARY', 'title': 'Procedural Factors Associated With Improved Yield (Biopsy Site)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'title': 'Nodule is in outer-third zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Nodule is in middle-third zone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with biopsy site (nodule location)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each trial arm is being split into two groups, whether the lung nodule is in the outer-third zone or middle-third zone. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.'}, {'type': 'SECONDARY', 'title': 'Need for Additional Nodule Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Additional Procedure for Staging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases in which a subsequent procedure was performed for staging', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiation Exposure From Fluoroscopy-guided Bronchoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '9800', 'groupId': 'OG000', 'lowerLimit': '7190', 'upperLimit': '18850'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months', 'description': 'Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy\\*cm\\^2)', 'unitOfMeasure': 'mGy*cm^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The NB arm has units of mGy\\*cm\\^2.'}, {'type': 'SECONDARY', 'title': 'Need for F-Nav During Navigation Bronchoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'Patients included are those that received the navigational bronchoscopy intervention'}, {'id': 'OG001', 'title': 'Diagnostic', 'description': 'Patients that received a diagnostic result from the navigational bronchoscopy intervention'}, {'id': 'OG002', 'title': 'Nondiagnostic', 'description': 'Patients that did not receive a diagnostic result from the navigational bronchoscopy intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Confident Clinical Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'OG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'The proportion of biopsy procedures yielding a confident clinical diagnosis including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Radiation Exposure From CT for CT-guided Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'classes': [{'categories': [{'measurements': [{'value': '659', 'groupId': 'OG000', 'lowerLimit': '253', 'upperLimit': '1276'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months', 'description': 'Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy\\*cm)', 'unitOfMeasure': 'mGy*cm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'CT-guided biopsy arm has units of mGy\\*cm'}, {'type': 'SECONDARY', 'title': 'Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'Patients included are those that received the CT-guided intervention'}, {'id': 'OG001', 'title': 'Diagnostic', 'description': 'Patients that received a diagnostic result from the CT-guided intervention'}, {'id': 'OG002', 'title': 'Nondiagnostic', 'description': 'Patients that did not receive a diagnostic result from the CT-guided intervention'}], 'classes': [{'title': 'Coaxial needle gauge : <19', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Coaxial needle gauge : 19', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Coaxial needle gauge : 20', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Coaxial needle gauge : Not used', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'FNA performed', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Core biopsies performed', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Core biopsy gauge: 18 or 19', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Core biopsy gauge: 20 or 21', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Any specimen cultured', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16 patients not included: CT performed on the day of the procedure demonstrated regressing nodules in 10 patients and the proceduralist decided to cancel in 6 patients. There were pre-specified exclusion criteria for this outcome measure.\n\nTwo patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'FG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Declined to schedule biopsy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Medically Unfit for Biopsy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'New data available meeting exclusion criterion: PET/CT with avid adenopathy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'New data available meeting exclusion criterion: interim CT demonstrated rapid growth to >30 mm', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'New data available meeting exclusion criterion: PET/CT with avid endobronchial lesion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '288 participants were consented, 30 participants were excluded prior to randomization:\n\n* Failed central adjudication of procedure feasibility (n=20)\n* Withdrawal of informed consent (n=5)\n* New data available meeting exclusion criterion (n=5)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Navigation Bronchoscopy (NB) With F-Nav', 'description': 'Navigation bronchoscopy: A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy'}, {'id': 'BG001', 'title': 'CT-guided Biopsy', 'description': 'CT-Guided Biopsy: Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '62', 'upperLimit': '72'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '61', 'upperLimit': '74'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Current or prior malignancy', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Obstructive Pulmonary Disease (COPD)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Coronary artery disease', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'groupId': 'BG000', 'lowerLimit': '23.9', 'upperLimit': '31.5'}, {'value': '27.9', 'groupId': 'BG001', 'lowerLimit': '24.0', 'upperLimit': '31.2'}, {'value': '27.7', 'groupId': 'BG002', 'lowerLimit': '24.0', 'upperLimit': '31.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Tobacco smoking history', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Non-smoker', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pack-years', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '55'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '47'}, {'value': '40.0', 'groupId': 'BG002', 'lowerLimit': '20.0', 'upperLimit': '52.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pack-years', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-29', 'size': 1498158, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-01T13:43', 'hasProtocol': True}, {'date': '2020-12-29', 'size': 1175036, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-17T10:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2020-01-29', 'resultsFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-11', 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following:\n\n* Malignant, OR\n* Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR\n* Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND\n* Absence of malignancy (true negative) through 1-year CT follow-up, defined as:\n\n * The nodule markedly regresses or resolves on follow-up imaging, OR\n * A persistent nodule has not been diagnosed as malignant, AND\n * No plans for repeat invasive diagnostic procedures through 12 months follow-up.\n\nNormal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Yield', 'timeFrame': 'Up to 12 months', 'description': 'Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.'}, {'measure': 'Rate of Pneumothorax', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases complicated by pneumothorax'}, {'measure': 'Rate of Pneumothorax Requiring Chest Tube Placement', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases complicated by pneumothorax requiring chest tube placement'}, {'measure': 'Need for Hospitalization After Procedure', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases with complication necessitating hospitalization after a procedure'}, {'measure': 'Duration of Procedure', 'timeFrame': 'Up to 12 months', 'description': 'Total time required to complete the procedure'}, {'measure': 'Procedural Factors Associated With Improved Yield (Type of Biopsy)', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.'}, {'measure': 'Procedural Factors Associated With Improved Yield (Number of Biopsies)', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.'}, {'measure': 'Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.'}, {'measure': 'Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with presence of a bronchus sign'}, {'measure': 'Procedural Factors Associated With Improved Yield (Biopsy Site)', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with biopsy site (nodule location)'}, {'measure': 'Need for Additional Nodule Biopsy', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed'}, {'measure': 'Need for Additional Procedure for Staging', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of cases in which a subsequent procedure was performed for staging'}, {'measure': 'Radiation Exposure From Fluoroscopy-guided Bronchoscopy', 'timeFrame': 'Up to 12 months', 'description': 'Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy\\*cm\\^2)'}, {'measure': 'Need for F-Nav During Navigation Bronchoscopy', 'timeFrame': 'Up to 12 months', 'description': 'Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.'}, {'measure': 'Confident Clinical Diagnosis', 'timeFrame': 'Up to 12 months', 'description': 'The proportion of biopsy procedures yielding a confident clinical diagnosis including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens.'}, {'measure': 'Radiation Exposure From CT for CT-guided Biopsy', 'timeFrame': 'Up to 12 months', 'description': 'Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy\\*cm)'}, {'measure': 'Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group', 'timeFrame': 'Up to 12 months', 'description': 'Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Nodule']}, 'referencesModule': {'references': [{'pmid': '40387025', 'type': 'DERIVED', 'citation': "Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Avasarala SK, Casey JD, Cheng GZ, D'Haese PF, Duke JD, Grogan EL, Hoopman TC, Johnson J, Katsis JM, Kurman JS, Low SW, Mahmood K, Rickman OB, Roller L, Salmon C, Shojaee S, Swanner B, Wahidi MM, Walston C, Silvestri GA, Yarmus L, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025 Jun 5;392(21):2100-2112. doi: 10.1056/NEJMoa2414059. Epub 2025 May 18."}, {'pmid': '38045245', 'type': 'DERIVED', 'citation': "Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Swanner B, Roller L, Low SW, Salmon C, Avasarala SK, Hoopman TC, Wahidi MM, Mahmood K, Cheng GZ, Katsis JM, Kurman JS, D'Haese PF, Johnson J, Grogan EL, Walston C, Yarmus L, Silvestri GA, Rickman OB, Rahman NM, Maldonado F. Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial. medRxiv [Preprint]. 2023 Nov 23:2023.11.22.23298915. doi: 10.1101/2023.11.22.23298915."}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:\n\n1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and\n2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.', 'detailedDescription': 'Endpoints:\n\nPrimary:\n\n• To evaluate diagnostic accuracy through 12 months of clinical follow-up\n\nSecondary:\n\n* To evaluate rate of pneumothorax.\n* To evaluate rate of pneumothorax requiring chest tube placement.\n* To evaluate clinically significant bleeding (defined by bleeding requiring intervention).\n* To evaluate need for hospitalization after procedure.\n* To evaluate duration of the procedure.\n* To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).\n* To evaluate need for additional nodule biopsy.\n* To evaluate need for additional procedure for staging.\n* To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.\n* To evaluate need for F-Nav (digital tomosynthesis) during navigation bronchoscopy.\n* To evaluate diagnostic yield\n* To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:\n\n * Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:\n\n * The Brock model14 if no PET scan data are available, or\n * The Herder model15 if PET-CT data are available.\n * Size between 10 and 30 mm (long diameter).\n * Location peripheral, here defined as occupying the middle or outer third lung zones.\n * Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.\n\nExclusion Criteria:\n\n* Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.\n* Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).'}, 'identificationModule': {'nctId': 'NCT04250194', 'acronym': 'VERITAS', 'briefTitle': 'Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)', 'orgStudyIdInfo': {'id': 'VICC THO 19102'}, 'secondaryIdInfos': [{'id': 'NCI-2020-00632', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation Bronchoscopy (NB) with F-Nav', 'interventionNames': ['Device: Navigation bronchoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'CT-guided Biopsy', 'interventionNames': ['Device: CT-Guided Biopsy']}], 'interventions': [{'name': 'CT-Guided Biopsy', 'type': 'DEVICE', 'description': 'Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing', 'armGroupLabels': ['CT-guided Biopsy']}, {'name': 'Navigation bronchoscopy', 'type': 'DEVICE', 'description': 'A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy', 'armGroupLabels': ['Navigation Bronchoscopy (NB) with F-Nav']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'Kootenai Health', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Fabien Maldonado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fabien Maldonado', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}