Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04260620
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRMC Analysis: ROC AUC', 'timeFrame': '8 Weeks', 'description': 'Area under the ROC curve (AUC)'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': '8 Weeks', 'description': 'True Positive Rate and True Negative Rate'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast Screening', 'Breast Imaging', 'SoftVue', 'Mammography', 'Ultrasound', 'Reader Study', 'ROC AUC', 'Dense Breasts', 'Breast Density', 'Dense Breast Tissue', 'Breast Neoplasms'], 'conditions': ['Breast Cancer Detection', 'Dense Breast Parenchyma', 'Benign Breast Findings', 'Normal Breast Screening', 'Abnormal Breast Screening']}, 'descriptionModule': {'briefSummary': 'The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma.\n\nThis reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Readers will evaluate mammography and SoftVue images acquired at study entry from consented participants in protocol DMT-2015.001, and subsequently categorized into the following case types, in random order:\n\n* Cancer cases, confirmed by breast biopsy with at least one lesion determined to be malignant during participation\n* Non-Cancer cases including, but not limited to benign cases, confirmed by breast biopsy with no lesions determined to be malignant, or normal/negative screening or diagnostic imaging during participation', 'healthyVolunteers': False, 'eligibilityCriteria': "Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate as study readers. All readers must meet the following base Inclusion Criteria:\n\n* Hold a current United States medical license\n* Be American Board of Radiology Certified\n* Be MQSA-qualified\n* Be experienced in reading DM images on a monitor\n* Be experienced in reading Breast Ultrasound images on a monitor\n* Have completed a Financial Disclosure showing no Conflicts of Interest\n* Have provided a current curriculum vitae (CV)\n* Have provided a signed Readers' Agreement\n* Have provided written Informed Consent\n\nAll qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study."}, 'identificationModule': {'nctId': 'NCT04260620', 'acronym': 'DMT SV RRS3', 'briefTitle': 'Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Delphinus Medical Technologies, Inc.'}, 'officialTitle': 'A Retrospective, Observational, Case-controlled, Multi-reader, Multi-case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma', 'orgStudyIdInfo': {'id': 'DMT-2019.002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Reading of Automated Breast Ultrasound in conjunction with Screening Mammography', 'type': 'DEVICE', 'otherNames': ['Digital Screening Mammography with Adjunctive SoftVue Screening Whole Breast Ultrasound'], 'description': 'Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48374', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Delphinus Medical Technologies, Inc.', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}], 'overallOfficials': [{'name': 'Yulei Jiang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delphinus Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'Boston Biomedical Associates', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}