Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 8:44 PM
Study NCT ID:
NCT04929132
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'pathology results of breast nodules'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CEUS', 'timeFrame': 'up to 3 months', 'description': 'if the result of CEUS is positiveļ¼the nodule was downgraded. if the result of CEUS is negative, the nodule was kept as BI RADS 4A category. Then all nodules were submitted to biopsy or surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Breast Cancer', 'Pathology']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).', 'detailedDescription': 'The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed to evaluated the added value in BI-RADS 4A nodules'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with nodules which were sonographically classified as BI-RADS 4 A breast lesion\n\nExclusion Criteria:\n\n(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.'}, 'identificationModule': {'nctId': 'NCT04929132', 'acronym': 'BIRADS', 'briefTitle': 'Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Added Value of Contrast-enhanced Ultrasound for BI RADS 4A Nodules Graded With the Breast Imaging Reporting and Data System', 'orgStudyIdInfo': {'id': 'SAHZhejiangU 123'}}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zimei LIN', 'role': 'CONTACT', 'email': 'kelaidia@163.com'}], 'facility': 'SAHZJU'}], 'centralContacts': [{'name': 'zimei Lin', 'role': 'CONTACT', 'email': 'kelaidia@163.com', 'phone': '15157171799'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}