Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONMammography
FFDM (Full-Field Digital mammography)
Sponsors
Lunit Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Female * 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve | Through study completion, an average of 6 months | Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve to measure the effectiveness of Investigational Device between CAD assited and unassisted environment |
Countries
United States
Outcome results
None listed