Breast Cancer Clinical Trial
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.
Any ethnic origin
Acquired with devices from two manufacturers: Hologic and GE
4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)
Previous core needle biopsy in breast for past 2 years
Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
Previous breast cancer
Lactating when taking screening mammograms
Presence of a breast implant in screening mammograms
Presence of a pacemaker in screening mammograms
Inadequate quality status such as insufficient anatomical coverage of screening mammograms
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
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