Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04692818
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2020-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Ultrasound Breast Imaging
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2020-12-30', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BI-RADS Score', 'timeFrame': 'Baseline', 'description': 'BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women ≥ 18 years of age.\n* solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)\n* lesion size of 3mm or larger\n\nExclusion Criteria:\n\n* \\< 18 years of age.\n* Lacking capacity to consent\n* Pregnant or lactating\n* Receiving cancer therapy such as chemotherapy or radiation therapy'}, 'identificationModule': {'nctId': 'NCT04692818', 'briefTitle': '3D Ultrasound Breast Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': '3D Multimodal Ultrasound Imaging for Breast Cancer', 'orgStudyIdInfo': {'id': '20-010751'}, 'secondaryIdInfos': [{'id': 'W81XWH-21-1-0063', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinically indicated breast tumor biopsy', 'description': 'Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed', 'interventionNames': ['Diagnostic Test: GE Logiq E10 clinical ultrasound scanner', 'Diagnostic Test: Verasonics research scanner']}], 'interventions': [{'name': 'GE Logiq E10 clinical ultrasound scanner', 'type': 'DIAGNOSTIC_TEST', 'description': '2D B-mode, Doppler, and shear wave elastography images of the lesion', 'armGroupLabels': ['Clinically indicated breast tumor biopsy']}, {'name': 'Verasonics research scanner', 'type': 'DIAGNOSTIC_TEST', 'description': '3D B-mode imaging, microvessel imaging, and shear wave elastography', 'armGroupLabels': ['Clinically indicated breast tumor biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rica Pol', 'role': 'CONTACT', 'email': 'Pol.Hanarica@mayo.edu', 'phone': '507-422-5118'}, {'name': 'Shigao Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christine lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Bobbie Ott', 'role': 'CONTACT', 'email': 'Ott.Bobbie@mayo.edu', 'phone': '507-293-0922'}], 'overallOfficials': [{'name': 'Shigao Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Christine Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}