Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT02786004
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Image Quality Assessment for Screening and Diagnostic Mammography
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'beth.heckel@med.ge.com', 'phone': '262-312-7269', 'title': 'Beth Heckel', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for the duration of subject participation in the study, which was approximately 2 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Full Field Digital Mammography', 'description': '2-dimensional breast imaging\n\nFull Field Digital Mammography', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Digital Breast Tomosynthesis', 'description': '3-dimensional breast imaging\n\nDigital Breast Tomosynthesis', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Acceptable Overall Clinical Image Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Field Digital Mammography', 'description': '2-dimensional breast imaging\n\nFull Field Digital Mammography'}, {'id': 'OG001', 'title': 'Digital Breast Tomosynthesis', 'description': '3-dimensional breast imaging\n\nDigital Breast Tomosynthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At enrollment completion approximately 3 months post initiation', 'description': 'Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists ("readers"). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Field Digital Mammography', 'description': 'Subjects underwent two-dimensional breast imaging.'}, {'id': 'OG001', 'title': 'Digital Breast Tomosynthesis', 'description': 'Subjects underwent three-dimensional breast imaging.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unanticipated Device Effect', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Device Defects', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, approximately 3 months', 'description': 'Safety-related endpoint data (adverse events, serious adverse event, unanticipated device effect, and device defects) were monitored from all subjects for the duration of their participation. Results were summarized by cohort.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-four subjects were enrolled into the study, of which 14 were enrolled into the FFDM cohort and 10 into the DBT cohort. One (1) subject was withdrawn from the DBT cohort but was followed for AE, SAE, and UADE for the duration of her participation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Full Field Digital Mammography', 'description': '2-dimensional breast imaging\n\nFull Field Digital Mammography'}, {'id': 'FG001', 'title': 'Digital Breast Tomosynthesis', 'description': '3-dimensional breast imaging\n\nDigital Breast Tomosynthesis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Full Field Digital Mammography', 'description': '2-dimensional breast imaging\n\nFull Field Digital Mammography'}, {'id': 'BG001', 'title': 'Digital Breast Tomosynthesis', 'description': '3-dimensional breast imaging\n\nDigital Breast Tomosynthesis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2016-05-24', 'resultsFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-19', 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Acceptable Overall Clinical Image Quality', 'timeFrame': 'At enrollment completion approximately 3 months post initiation', 'description': 'Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists ("readers"). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012).'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.', 'timeFrame': 'Through study completion, approximately 3 months', 'description': 'Safety-related endpoint data (adverse events, serious adverse event, unanticipated device effect, and device defects) were monitored from all subjects for the duration of their participation. Results were summarized by cohort.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Health']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to determine the image quality of images using a new investigational medical imaging device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are women aged 40 years or older (≥40 years old);\n2. Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;\n3. Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;\n4. Are able to walk without assistive devices;\n5. Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and\n6. Are willing to provide written informed consent to participate.\n\nExclusion Criteria:\n\n1. Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;\n2. Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;\n3. Are currently lactating;\n4. Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or\n5. If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).'}, 'identificationModule': {'nctId': 'NCT02786004', 'briefTitle': 'Image Quality Assessment for Screening and Diagnostic Mammography', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)', 'orgStudyIdInfo': {'id': '124.03-2015-GES-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full Field Digital Mammography', 'description': '2-dimensional breast imaging', 'interventionNames': ['Device: Full Field Digital Mammography']}, {'type': 'EXPERIMENTAL', 'label': 'Digital Breast Tomosynthesis', 'description': '3-dimensional breast imaging', 'interventionNames': ['Device: Digital Breast Tomosynthesis']}], 'interventions': [{'name': 'Full Field Digital Mammography', 'type': 'DEVICE', 'otherNames': ['2D Mammography'], 'armGroupLabels': ['Full Field Digital Mammography']}, {'name': 'Digital Breast Tomosynthesis', 'type': 'DEVICE', 'otherNames': ['DBT'], 'armGroupLabels': ['Digital Breast Tomosynthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Breast Imaging Specialist', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Bruce Schroeder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Breast Imaging Specialists'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}