Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT03196635
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2017-06-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient-Assisted Compression - Impact on Image Quality and Workflow
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sara.j.lam@ge.com', 'phone': '262-548-2369', 'title': 'Sara Lam', 'organization': 'GE Healthcare'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for the duration of subject participation in the study, which was less than 1 month. Each subject was followed for Adverse Events from the time she entered the imaging suite for her exam until the time she exited the imaging suite after the exam.', 'description': 'The definition of adverse events and/or serious adverse events aligns with the definitions provided by clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'All Study Participants', 'description': 'Except for one subject who withdrew from the study prior to imaging procedures, all subjects underwent their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (CC and MLO) image acquisition. In addition, a study-specific, unilateral 2-view image set was obtained, utilizing the patient-assisted breast compression mode.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '60 image sets (30 PA and 30 TC compression image sets from 30 participants) were evaluated for acceptability of overall clinical image quality by two readers. The one (1) withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.'}, {'type': 'SECONDARY', 'title': 'Repeat Image Acquisition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Image sets', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'Repeat imaging for PA compression image sets were indicated for each subject by technologists during image acquisitions and by readers during image evaluations.'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'Repeat imaging for TC compression image sets were indicated for each subject by technologists during image acquisitions and by readers during image evaluations.'}], 'classes': [{'title': 'Technologist-indicated Repeat', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Reader-indicated Repeat', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.', 'unitOfMeasure': 'Image sets', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Image sets', 'denomUnitsSelected': 'Image sets', 'populationDescription': "Instances of repeat imaging for each subject's PA (N=30) and TC (N=30) image sets were indicated by technologists during image acquisitions and by readers during image evaluations. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set."}, {'type': 'SECONDARY', 'title': 'Acceptability of Mammographic Attributes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'All image sets (30 PA compression image sets) were evaluated for acceptability of specific mammographic attributes by two (2) readers. Both readers evaluated all image sets from all available subjects.'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'All image sets (30 TC compression image sets) were evaluated for acceptability of specific mammographic attributes by two (2) readers. Both readers evaluated all image sets from all available subjects.'}], 'classes': [{'title': 'Acceptable Breast Positioning', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable exposure and visualization of tissue', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable breast compression', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable image contrast', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable sharpness of the image', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable tissue visibility at the skin line', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable noise level of the image', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable artifacts level', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.', 'unitOfMeasure': 'image sets', 'reportingStatus': 'POSTED', 'populationDescription': 'The PA and TC image sets for all 30 subjects were evaluated for acceptability of pre-defined set of mammography attributes by Readers 1 and 2. Adjudication was not required if there was disagreement between the readers. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of Image Acquisition Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'Total image acquisition time was collected for each image set'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'Total image acquisition time was collected for each image set.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Imaging time was collected for each image set. 4 image sets were excluded from TC analysis due to repeat imaging per standard of care; repeat imaging wasn't allowed for PA compression. 1 subject's PA \\& TC image sets were excluded from analysis due to a protocol deviation. 1 withdrawn subject did not undergo imaging, so was not part of the analysis."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Technologist Interventions in PA Compression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Technologists were asked to document if any intervention on compression was required during the PA compression procedures. If so, clarification regarding what type of intervention was performed was requested.'}], 'classes': [{'categories': [{'title': 'Technologist had to increase compression', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Technologist had to decrease compression', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No intervention required', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects underwent PA compression on their assigned Breast of Interest. Technologists were asked to provide confirmation if any intervention was necessary while the subject was controlling the compression. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compression Force for PA and TC Compressions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Image Views', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'Compression force (daN) was captured for each view under Patient-Assisted Compression.'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'Compression force (daN) was captured for each view under Technologist Compression.'}], 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '9.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'MLO', 'categories': [{'measurements': [{'value': '8.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Compression forces (decanewton \\[daN\\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.', 'unitOfMeasure': 'daN', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Image Views', 'denomUnitsSelected': 'Image Views', 'populationDescription': 'Compression force (daN) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Breast Thickness for PA and TC Compressions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Image Views', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'Breast Thickness (mm) was captured for each view under PA Compression.'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'Breast Thickness (mm) was captured for each view under TC compression.'}], 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '52.0', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'MLO', 'categories': [{'measurements': [{'value': '54.6', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Breast thickness (millimeter \\[mm\\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Image Views', 'denomUnitsSelected': 'Image Views', 'populationDescription': 'Breast thickness (mm) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Radiation Dose for PA and TC Compressions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'Image Views', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants, PA Compression Image Sets', 'description': 'ESAK (mGy) was captured for each view under PA Compression.'}, {'id': 'OG001', 'title': 'All Study Participants, TC Compression Image Sets', 'description': 'ESAK (mGy) was captured for each view under TC compression.'}], 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'MLO', 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Radiation dose (entrance skin air kerma \\[ESAK\\] in milligray \\[mGy\\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.', 'unitOfMeasure': 'mGy', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Image Views', 'denomUnitsSelected': 'Image Views', 'populationDescription': 'ESAK was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocuadal \\[CC\\] and mediolateral oblique \\[MLO\\]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (CC/MLO) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode.\n\nPatient-Assisted Breast Compression: The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC/MLO.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast of Interest', 'classes': [{'categories': [{'title': 'First breast of interest', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Second breast of interest', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Withdrawn subject', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "One breast per eligible subject was randomly assigned as her 'breast of interest' which underwent study-specific procedures and image evaluations. Randomization of breast of interest was performed so that approximately half the subjects were assigned to the first breast imaged and the other half was assigned to the second breast imaged. The laterality of the breast of interest depended on which breast (left or right) the technologist imaged first and second in standard practice.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subject population consisted of adult women (\\>/= 40 years of age) clinically indicated for an FFDM exam.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-22', 'size': 1319635, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-09-18T12:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2017-06-19', 'resultsFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-03', 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of Image Acquisition Time', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.'}, {'measure': 'Technologist Interventions in PA Compression', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.'}, {'measure': 'Compression Force for PA and TC Compressions', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Compression forces (decanewton \\[daN\\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.'}, {'measure': 'Breast Thickness for PA and TC Compressions', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Breast thickness (millimeter \\[mm\\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.'}, {'measure': 'Radiation Dose for PA and TC Compressions', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Radiation dose (entrance skin air kerma \\[ESAK\\] in milligray \\[mGy\\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.'}], 'primaryOutcomes': [{'measure': 'Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.'}], 'secondaryOutcomes': [{'measure': 'Repeat Image Acquisition', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.'}, {'measure': 'Acceptability of Mammographic Attributes', 'timeFrame': 'Through study completion, on average 1 month', 'description': 'Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled \\[TC\\]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.', 'detailedDescription': "Patient-assisted (PA) compression allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. GE Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and PA compression modes. This study is being conducted to compare the image quality of breast images obtained using TC compression and PA compression, and to evaluate the impact of PA compression on clinical workflow. The study population will consist of adult asymptomatic women presenting for screening 2D mammography."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Asymptomatic women, aged 40 years or older scheduled for FFDM screening mammography', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are women aged 40 years or older;\n* Are asymptomatic and scheduled for FFDM screening mammography;\n* Have left and right breasts;\n* Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;\n* Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;\n* Are able and willing to comply with study procedures; and\n* Are able and willing to provide written informed consent to participate.\n\nExclusion Criteria:\n\n* Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;\n* Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;\n* Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;\n* Are currently lactating; or\n* Have breast implants."}, 'identificationModule': {'nctId': 'NCT03196635', 'briefTitle': 'Patient-Assisted Compression - Impact on Image Quality and Workflow', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Patient-Assisted Compression - Impact on Image Quality and Workflow', 'orgStudyIdInfo': {'id': '124.03-2017-GES-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Study Participants', 'description': 'All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocaudal \\[CC\\] and mediolateral oblique \\[MLO\\]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the PA breast compression mode.', 'interventionNames': ['Device: Patient-Assisted (PA) Breast Compression', 'Device: Technologist-Controlled (TC) Breast Compression']}], 'interventions': [{'name': 'Patient-Assisted (PA) Breast Compression', 'type': 'DEVICE', 'description': 'The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC \\& MLO.', 'armGroupLabels': ['All Study Participants']}, {'name': 'Technologist-Controlled (TC) Breast Compression', 'type': 'DEVICE', 'description': 'TC compression will be conducted per standard of care practices at the site.', 'armGroupLabels': ['All Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'overallOfficials': [{'name': 'Kathy Schilling', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boca Raton Regional Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}