Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT05840094
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodalitic Imaging in the N-stage of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC', 'timeFrame': '1 year', 'description': 'Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of three multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients.'}], 'secondaryOutcomes': [{'measure': 'The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC', 'timeFrame': '1 year', 'description': 'Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of two multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients.'}, {'measure': 'The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC', 'timeFrame': '1 year', 'description': 'Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of two multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-FDG PET/CT', 'Neoplasm of Lung', 'EBUS-TBNA', 'MR STIR', 'NSCLC N-stage'], 'conditions': ['Neoplasm of Lung']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the diagnostic efficacy and differences between 18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA, 18F-FDG PET/CT combined with EBUS-TBNA, and MR STIR sequences combined with EBUS-TBNA - three types of multimodal imaging for assessing NSCLC N-stage, in order to select the best assessment protocol to guide treatment decisions and prognostic assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy pathologically confirmed NSCLC, or clinically highly suspicious NSCLC (assessed as highly suspicious by the MDT team of this study);\n* N1, N2, or N3 confined to the mediastinum and hilum, as assessed by imaging;\n* Proposed systematic lymph node dissection without any treatment;\n* Appropriate laboratory tests (serum tumor markers);\n* All examination intervals ≤ 4 weeks;\n* KPS score ≥ 50 (ECOG/WHO equivalent);\n* Aged \\> 18 years; 8. Patients can fully understand and voluntarily participate in this trial and sign the informed consent; the examination can be completed independently.\n\nExclusion Criteria:\n\n* Contraindication to EBUS-TBNA operation;\n* Presence or history of other malignancies within 10 years;\n* Inability to understand the examination procedure or to cooperate.'}, 'identificationModule': {'nctId': 'NCT05840094', 'briefTitle': 'Multimodalitic Imaging in the N-stage of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'A Prospective Study of the Predictive and Prognostic Value of Multimodalitic Imaging in the N-stage of Lung Cancer', 'orgStudyIdInfo': {'id': 'LCN001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET/CT+MR+EBUS', 'description': 'Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC', 'interventionNames': ['Drug: 18F-FDG', 'Device: MR STIR', 'Procedure: EBUS-TBNA']}, {'type': 'EXPERIMENTAL', 'label': 'PET/CT+EBUS', 'description': 'Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC', 'interventionNames': ['Drug: 18F-FDG', 'Procedure: EBUS-TBNA']}, {'type': 'EXPERIMENTAL', 'label': 'MR+EBUS', 'description': 'Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC', 'interventionNames': ['Device: MR STIR', 'Procedure: EBUS-TBNA']}], 'interventions': [{'name': '18F-FDG', 'type': 'DRUG', 'description': '18F-FDG is injected intravenously with a dose of 0.1mCi/kg.', 'armGroupLabels': ['PET/CT+EBUS', 'PET/CT+MR+EBUS']}, {'name': 'MR STIR', 'type': 'DEVICE', 'description': 'The overall scanning time of MR is about 13min.', 'armGroupLabels': ['MR+EBUS', 'PET/CT+MR+EBUS']}, {'name': 'EBUS-TBNA', 'type': 'PROCEDURE', 'description': 'Puncture about 20 times, 3 stitches in each group of enlarged lymph nodes, 1 stitch in the anterior, middle and posterior parts respectively', 'armGroupLabels': ['MR+EBUS', 'PET/CT+EBUS', 'PET/CT+MR+EBUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Meng Liu', 'role': 'CONTACT', 'email': 'louisa_liu@bjmu.edu.cn', 'phone': '13261995618'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Meng Liu', 'role': 'CONTACT', 'email': 'louisa_liu@bjmu.edu.cn', 'phone': '+86 13261995618'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}