Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-24 @ 8:48 AM
Study NCT ID:
NCT03708393
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2018-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imagio Feasibility Multi-Reader, Multi-Case Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}}}}, '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'}]}, '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': 'sschaeffer@senomedical.com', 'phone': '610-698-3259', 'title': 'Shaan Schaeffer VP of Clinical Operations', 'organization': 'Seno Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 12 months +/- 30 days follow-up. Adverse Events were recorded from the use of the Imagio during the original PIONEER Study and reported out for those participants/masses selected for the Reader-01 Independent Reader Study.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall (Masses Randomly Selected From PIONEER-01 Study)', 'description': 'Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, safety data are for overall population only.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 0, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IUS Alone', 'description': 'IUS alone imaging'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging'}], 'classes': [{'title': 'fSp (95.0%)', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '92.7'}, {'value': '75.4', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '89.3'}]}]}, {'title': 'fSp (96.0%)', 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '91.7'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '87.0'}]}]}, {'title': 'fSp (97.0%)', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '90.3'}, {'value': '66.1', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '83.7'}]}]}, {'title': 'fSp (97.5%)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '89.4'}, {'value': '62.8', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '81.6'}]}]}, {'title': 'fSp (98.0%)', 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '88.3'}, {'value': '58.9', 'groupId': 'OG001', 'lowerLimit': '38.8', 'upperLimit': '79'}]}]}, {'title': 'fSp (99.0%)', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '84.6'}, {'value': '47.7', 'groupId': 'OG001', 'lowerLimit': '24.5', 'upperLimit': '71.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 month follow-up', 'description': 'Primary effectiveness endpoint was the specificity of Imagio \\[IUS+OA\\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for each subject (subject as own control). Results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth).', 'unitOfMeasure': 'Percent of correct benign masses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '120 patients/masses were included in Cohort 1-the Intent-to-diagnose (ITD) population used to run the analysis to set the sample size for the future pivotal Reader-02 Study, 30 masses Cohort 2 to assess False negative rate, and 5 Cohort 3 DCIS, lymphoma, etc. masses to assess how readers scored. 155 masses in total across all cohorts analyzed for the Safety population analysis'}, {'type': 'SECONDARY', 'title': 'Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio IUS', 'description': 'Read 1 - Mammo (as available) + Imagio Ultrasound\n\nImagio Ultrasound: Imagio ultrasound images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)\n\nImagio (IUS+OA): The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)', 'description': 'pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \\[IUS+OA\\] vs. IUS alone; averaged across 10 readers.', 'unitOfMeasure': 'Probability as percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1, pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \\[IUS+OA\\] vs. IUS alone; averaged across 10 readers.'}, {'type': 'SECONDARY', 'title': 'BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio IUS', 'description': 'Read 1 - Mammo (as available) + Imagio Ultrasound\n\nImagio Ultrasound: Imagio ultrasound images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)\n\nImagio (IUS+OA): The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads', 'unitOfMeasure': '% of correctly identified benign masses', 'reportingStatus': 'POSTED', 'populationDescription': 'ITD Population- Number of Subjects/Masses 120'}, {'type': 'SECONDARY', 'title': 'The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IUS Alone', 'description': 'Results for IUS alone readings'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging\n\nResults for Imagio readings'}], 'classes': [{'categories': [{'measurements': [{'value': '.049', 'groupId': 'OG000', 'lowerLimit': '.04', 'upperLimit': '.07'}, {'value': '.094', 'groupId': 'OG001', 'lowerLimit': '.08', 'upperLimit': '.11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)', 'description': 'NLR (Imagio \\[IUS+OA\\] vs. IUS alone); averaged across 10 readers (all readers).', 'unitOfMeasure': 'Ratio', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1 - 120'}, {'type': 'SECONDARY', 'title': 'SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio IUS', 'description': 'Read 1 - Mammo (as available) + Imagio Ultrasound\n\nImagio Ultrasound: Imagio ultrasound images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)\n\nImagio (IUS+OA): The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1'}, {'type': 'SECONDARY', 'title': 'SenoGram Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio IUS', 'description': 'Read 1 - Mammo (as available) + Imagio Ultrasound\n\nImagio Ultrasound: Imagio ultrasound images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)\n\nImagio (IUS+OA): The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study\n\nMammography: Mammography images as available per standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'SenoGram not used for IUS Arm', 'groupId': 'OG000'}, {'value': '98.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'Sensitivity of SenoGram estimated from cross-validation - Cohort 1', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'ITD Population'}, {'type': 'SECONDARY', 'title': 'SenoGram Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IUS Alone', 'description': 'Results for IUS alone readings'}, {'id': 'OG001', 'title': 'Imagio (IUS+OA)', 'description': 'IUS+OA imaging\n\nResults for Imagio readings'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'SenoGram not used for IUS Arm', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'Specificity of SenoGram estimated from cross-validation', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'ITD Population - Cohort 1'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall (Subjects Randomly Selected From PIONEER-01 Study)', 'description': "Each subject in all 3 cohorts had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. All subjects for all 3 cohorts were included in safety analysis. All subjects for all 3 cohorts were followed and completed in the same manner. Cohort 1 (n=120 was representative of the subject population for the primary analysis, Cohort 2 (n=30) was special population for internal study of FN's and Cohort 3 (n=5) was for internal study of DCIS masses."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'New Independent Reader Feasibility Study (new readers re-reading a sub-set of randomly selected images acquired during PIONEER-01 Study (NCT01943916); Reader-01 study execution dates: 13 Nov 2018 to 6 Dec 2018', 'preAssignmentDetails': 'Breast mass images were acquired during PIONEER-01 study. The Reader-01 study-single arm, sequentially read (IUS vs. Imagio \\[IUS+OA\\]), controlled, blinded, multi-reader, multi-case (MRMC) feasibility study. New readers recruited; NO new subjects were recruited. Subject baseline, demographic and safety data comes from PIONEER-01 subjects who were randomly selected for Reader-01 study. Outcome measures compared IUS vs. IUS+OA. Truth based on biopsy diagnosis or 12 Mo F/U truth panel decision.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall (Subjects Randomly Selected From PIONEER-01 Study)', 'description': 'Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data are for overall population only.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '14.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '155', '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': '24', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '130', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mass Diagnosis', 'classes': [{'categories': [{'title': 'Subjects: Benign (includes benign + Truth Panel Benign [TPB]) (Cohort 1)', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'Subjects: Malignant (Cohort 1)', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Subjects: Malignant false negative in PIONEER-01 (Cohort 2)', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Subjects: Malignant atypical (Cohort 3)', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mass diagnosis by (biopsy result or Truth Panel decision = TPB) TPB was determined as ground truth obtained during the PIONEER-01 Study.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-diagnose (ITD)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-01', 'size': 713656, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-27T20:08', 'hasProtocol': True}, {'date': '2018-11-09', 'size': 397462, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-27T17:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Independent Readers blinded to mass diagnosis'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 5-12 independent readers depending on qualifications and availability.\n\nImagio (IUS+OA) Training to be completed prior to any reads taking place. Read 1 is immediately followed by Read 2 within the same read session.\n\nRead 1 (Control): Mammogram (if available) + History + IUS (stills and videos provided), IUS Probability of Malignancy (POM) and BI-RADS scored and the data form locked.\n\nRead 2 (Test): Mammogram (if available) + History + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). An interim IUS POM and BI-RADS is recorded as well as a combined Imagio (IUS+OA) POM and BIRADS Pre and Post SenoGram on separate data forms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2020-04-01', 'completionDateStruct': {'date': '2018-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2018-09-28', 'dispFirstSubmitQcDate': '2021-07-14', 'resultsFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2018-10-11', 'dispFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-14', 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1', 'timeFrame': 'Baseline to 12 month follow-up', 'description': 'Primary effectiveness endpoint was the specificity of Imagio \\[IUS+OA\\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for each subject (subject as own control). Results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth).'}], 'secondaryOutcomes': [{'measure': 'Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)', 'description': 'pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \\[IUS+OA\\] vs. IUS alone; averaged across 10 readers.'}, {'measure': 'BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads'}, {'measure': 'The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)', 'description': 'NLR (Imagio \\[IUS+OA\\] vs. IUS alone); averaged across 10 readers (all readers).'}, {'measure': 'SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)'}, {'measure': 'SenoGram Performance', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'Sensitivity of SenoGram estimated from cross-validation - Cohort 1'}, {'measure': 'SenoGram Performance', 'timeFrame': 'Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months', 'description': 'Specificity of SenoGram estimated from cross-validation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Controlled, blinded, multi-reader, multi-case study', 'detailedDescription': 'The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status\n\nExclusion Criteria:\n\n\\- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status'}, 'identificationModule': {'nctId': 'NCT03708393', 'briefTitle': 'Imagio Feasibility Multi-Reader, Multi-Case Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seno Medical Instruments Inc.'}, 'officialTitle': 'Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy', 'orgStudyIdInfo': {'id': 'Reader-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Imagio IUS', 'description': 'Read 1 - Mammo (as available) + Imagio Ultrasound', 'interventionNames': ['Device: Imagio Ultrasound', 'Device: Mammography']}, {'type': 'EXPERIMENTAL', 'label': 'Imagio (IUS+OA)', 'description': 'Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)', 'interventionNames': ['Device: Imagio (IUS+OA)', 'Device: Mammography']}], 'interventions': [{'name': 'Imagio (IUS+OA)', 'type': 'DEVICE', 'description': 'The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study', 'armGroupLabels': ['Imagio (IUS+OA)']}, {'name': 'Imagio Ultrasound', 'type': 'DEVICE', 'description': 'Imagio ultrasound images to be reviewed as part of the reader study', 'armGroupLabels': ['Imagio IUS']}, {'name': 'Mammography', 'type': 'DEVICE', 'otherNames': ['Mammo'], 'description': 'Mammography images as available per standard of care', 'armGroupLabels': ['Imagio (IUS+OA)', 'Imagio IUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'American College of Radiology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'A. Thomas Stavros, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seno Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seno Medical Instruments Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'American College of Radiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}