Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-21 @ 9:06 PM
Study NCT ID:
NCT05518669
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mCBCT in Combination With ENB for the Diagnosis of PPNs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield improvement ratio', 'timeFrame': 'Up to at least 6 months', 'description': 'Diagnostic yield improvement ratio, defined as Post-mCBCT diagnostic yield minus Pre-mCBCT diagnostic yield.\n\nThe Pre-mCBCT diagnostic yield, defined as the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and without any adjustment after first time mCBCT spin during the procedure in all enrolled subjects.\n\nThe Post-mCBCT diagnostic yield, defined as the proportion of diagnosed patients including those with and without adjustment after mCBCT spin in all enrolled subjects.\n\nDiagnostic yield was defined as all instances in which the results of bronchoscopy matched the final diagnoses.'}], 'secondaryOutcomes': [{'measure': 'Pre-mCBCT navigational yield', 'timeFrame': 'Intra-procedure', 'description': 'The proportion of patients who was confirmed tool-in-lesion by the first time mCBCT spin and no need for further adjustment in all enrolled subjects.'}, {'measure': 'Post-mCBCT navigational yield', 'timeFrame': 'Intra-procedure', 'description': 'The proportion of patients who was confirmed tool-in-lesion with and without adjustment by mCBCT in all enrolled subjects.'}, {'measure': 'Total radiation dose', 'timeFrame': 'Intra-procedure', 'description': 'Radiation dose from procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm\\^2).'}, {'measure': 'Fluoroscopy time', 'timeFrame': 'Intra-procedure', 'description': 'The fluoroscopy time during the procedure.'}, {'measure': 'Adjustment time', 'timeFrame': 'Intra-procedure', 'description': 'The adjustment time during the procedure, defined as the time between the first mCBCT spin scanning to final spin scanning.'}, {'measure': 'Total operation time', 'timeFrame': 'Intra-procedure', 'description': 'The total operation time was defined as the time from bronchoscope insertion to withdrawal of the glottis.'}, {'measure': 'Factors affecting diagnostic yield', 'timeFrame': 'Up to at least 6 months', 'description': 'The factors affecting diagnostic yield includes the nodule nature, nodule size, nodule location, bronchus sign on CT, etc.'}, {'measure': 'Complication rate', 'timeFrame': 'Up to 1 month', 'description': 'The complications refer to the proportion of serious adverse events related to the procedure during or within 1 month after the operation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Pulmonary Nodules', 'Diagnosis', 'Mobile Cone-Beam CT', 'Electromagnetic Navigation Bronchoscopy'], 'conditions': ['Peripheral Pulmonary Nodules', 'Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '30746241', 'type': 'BACKGROUND', 'citation': 'Casal RF, Sarkiss M, Jones AK, Stewart J, Tam A, Grosu HB, Ost DE, Jimenez CA, Eapen GA. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018 Dec;10(12):6950-6959. doi: 10.21037/jtd.2018.11.21.'}, {'pmid': '35509435', 'type': 'BACKGROUND', 'citation': 'Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun.'}, {'pmid': '34291295', 'type': 'BACKGROUND', 'citation': 'Hsieh MJ, Chou PL, Fang HY, Wen CT, Chao YK. Single-step localization and excision of small pulmonary nodules using a mobile 3D C-arm. Interact Cardiovasc Thorac Surg. 2021 Nov 22;33(6):885-891. doi: 10.1093/icvts/ivab182.'}, {'pmid': '34430367', 'type': 'BACKGROUND', 'citation': 'Chen J, Xie F, Zheng X, Li Y, Liu S, Ma KC, Goto T, Muller T, Chan ED, Sun J. Mobile 3-dimensional (3D) C-arm system-assisted transbronchial biopsy and ablation for ground-glass opacity pulmonary nodules: a case report. Transl Lung Cancer Res. 2021 Jul;10(7):3312-3319. doi: 10.21037/tlcr-21-561.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.', 'detailedDescription': 'This study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. The investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3D imaging findings of mCBCT. The value of mCBCT in improving diagnostic yield is explored by comparing the diagnostic yield Post-mCBCT with that of Pre-mCBCT. The Pre-mCBCT diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mCBCT spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield is the proportion of diagnosed patients with and without adjustment after mCBCT spin during the procedure in all enrolled subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the presence of pulmonary peripheral nodules on chest CT imaging suspicion of malignancy that need to obtain pathologic diagnosis by transbronchial lung biopsy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject with age of 18 years and older\n* Chest CT imaging shows the presence of peripheral pulmonary nodules (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) suspicion of malignancy that need to be confirmed by pathology\n* Pulmonary nodules of \\> 8mm and ≤30 mm in largest dimension\n* Patients without contraindications of bronchoscopy\n* Patients have good medical adherence and signed informed consent\n\nExclusion Criteria:\n\n* Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy\n* Presence of concomitant endobronchial lesion during the bronchoscopy procedure\n* Pre-operative mCBCT spin scan showed no visible lesions"}, 'identificationModule': {'nctId': 'NCT05518669', 'briefTitle': 'mCBCT in Combination With ENB for the Diagnosis of PPNs', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Mobile Cone-Beam CT in Combination With Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules', 'orgStudyIdInfo': {'id': 'SHCHE202207'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peripheral Pulmonary Nodules', 'description': 'Patients with peripheral pulmonary nodules on chest computed tomography suspicion of malignancy who are scheduled to reach the target lesion for diagnosis by mobile cone-beam CT combined with electromagnetic navigation bronchoscopy.', 'interventionNames': ['Device: Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)']}], 'interventions': [{'name': 'Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)', 'type': 'DEVICE', 'description': 'Subjects with biopsy of peripheral pulmonary nodule using electromagnetic navigation bronchoscopy and mobile cone-beam CT.', 'armGroupLabels': ['Peripheral Pulmonary Nodules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayuan Sun, MD', 'role': 'CONTACT', 'email': 'jysun1976@163.com'}, {'name': 'Jiayuan Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiayuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'jysun1976@163.com', 'phone': '86-21-22200000', 'phoneExt': '1511'}], 'overallOfficials': [{'name': 'Jiayuan Sun, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital', 'investigatorFullName': 'Jiayuan Sun', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}