Study Results
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View full resultsBasic Information
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COMPLETED
NA
480 participants
INTERVENTIONAL
2019-07-30
2019-11-03
Brief Summary
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Detailed Description
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Imagio® \[Ultrasound (IUS) + Optoacoustic (OA)\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
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Imagio IUS
Read 1 (Control): History + Mammogram (if available) + IUS (Imagio Ultrasound) stills and videos provided), IUS Probability of Malignancy (POM) and Breast Imaging Reporting and Data System (BI-RADS) scored and the data form then locked.
Reader Study - Imagio Ultrasound
Imagio ultrasound images to be reviewed as part of Reader study
Mammography
Mammography as available per standard of care
Imagio (IUS+OA)
Read 2 (Test): History + Mammogram (if available) + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). Imagio (IUS+OA) POM and Breast Imaging Reporting and Data System (BI-RADS) assigned after viewing the SenoGram® output. The dataform is locked.
Reader Study Imagio Ultrasound + Optoacoustic Imaging
Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study
Mammography
Mammography as available per standard of care
Interventions
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Reader Study - Imagio Ultrasound
Imagio ultrasound images to be reviewed as part of Reader study
Reader Study Imagio Ultrasound + Optoacoustic Imaging
Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study
Mammography
Mammography as available per standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient age, indication for study entry and available medical history
* Evaluable mammograms and OA and IUS video loops and stills for each mass
Exclusion Criteria
* Reader-02 Proficiency Test and training cases
18 Years
FEMALE
No
Sponsors
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Seno Medical Instruments Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shaan Schaeffer
Role: STUDY_DIRECTOR
Seno Medical
Locations
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American College of Radiology Center for Research and Innovation
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Reader-02 Study
Identifier Type: -
Identifier Source: org_study_id
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