Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-28 @ 2:54 AM
Study NCT ID:
NCT06025461
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'elasticity imaging/B-mode ratio', 'timeFrame': 'Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography', 'description': 'The ratio of lesion length on strain elastography images to lesion length on grayscale images'}, {'measure': 'shear wave velocity', 'timeFrame': 'Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography', 'description': 'Shear wave velocity values at the hardest point of the lesion and surrounding tissues'}, {'measure': 'strain ratio', 'timeFrame': 'Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography', 'description': 'The ratio of average strain between surrounding tissues at the same depth and the lesion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Disease']}, 'descriptionModule': {'briefSummary': 'Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.\n\nMaterials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Perform ultrasound examination at our hospital before surgery or puncture biopsy; Complete histopathological data; Two ultrasound physicians with more than 5 years of experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on preoperative ultrasound images.\n\nExclusion Criteria:\n\n* Poor image quality; Incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT06025461', 'briefTitle': 'Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions', 'orgStudyIdInfo': {'id': 'YXLL-KY-2023(012)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fibroadenoma group', 'interventionNames': ['Other: no intervention']}, {'label': 'breast hyperplasia group', 'interventionNames': ['Other: no intervention']}, {'label': 'other types of benign nodules group', 'interventionNames': ['Other: no intervention']}, {'label': 'non-specific invasive carcinoma group', 'interventionNames': ['Other: no intervention']}, {'label': 'other types of breast cancer group', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['breast hyperplasia group', 'fibroadenoma group', 'non-specific invasive carcinoma group', 'other types of benign nodules group', 'other types of breast cancer group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shandong', 'country': 'China', 'facility': 'QianfoshanH', 'geoPoint': {'lat': 40.28464, 'lon': 120.48412}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ma Zhe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Ultrasound', 'investigatorFullName': 'Ma Zhe', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}