Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT03802266
Status:
UNKNOWN
Last Update Posted:
2019-01-14
First Post:
2019-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 322}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic rate', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Operating time', 'timeFrame': '18 months'}, {'measure': 'Adverse events', 'timeFrame': '18 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.\n\nPrimary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;\n2. Patients who are older than 18 year-old;\n3. Patients voluntarily join the study and give written informed consent for the study.\n\nExclusion Criteria:\n\n1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.\n2. Large blood vessels or important structures on the puncture path of peripheral lung tumors；\n3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy."}, 'identificationModule': {'nctId': 'NCT03802266', 'briefTitle': 'Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial', 'orgStudyIdInfo': {'id': 'Chest 010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electromagnetic Navigation group', 'description': 'Electromagnetic Navigation Guided Transthoracic Needle Aspiration', 'interventionNames': ['Device: Electromagnetic Navigation guided transthoracic needle aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CT group', 'description': 'CT-guided Transthoracic Needle Aspiration', 'interventionNames': ['Device: CT-guided Transthoracic Needle Aspiration']}], 'interventions': [{'name': 'Electromagnetic Navigation guided transthoracic needle aspiration', 'type': 'DEVICE', 'description': 'Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule', 'armGroupLabels': ['Electromagnetic Navigation group']}, {'name': 'CT-guided Transthoracic Needle Aspiration', 'type': 'DEVICE', 'description': 'Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule', 'armGroupLabels': ['CT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Zhong, MD,PhD', 'role': 'CONTACT', 'email': 'eddiedong8@hotmail.com', 'phone': '86-21-22200000', 'phoneExt': '3902'}, {'name': 'Shuhui Cao, MD', 'role': 'CONTACT', 'email': 'caosh1994@163.com', 'phone': '86-21-22200000', 'phoneExt': '3909'}], 'facility': 'Shanghai Chest hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hua Zhong, Phd，MD', 'role': 'CONTACT', 'email': 'eddiedong8@hotmail.com', 'phone': '13818200560'}], 'overallOfficials': [{'name': 'Hua Zhong, Phd，MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Third Military Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Hua Zhong', 'investigatorFullName': 'Hua Zhong', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}