Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Mammography


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer<br>Negative image data: Has been interpreted as negative in screening mammograms Benign image data: Has a suspicious lesion for breast cancer in screening mammograms but confirmed as a benign through the follow-up biopsy or has been interpreted as a benign in screening mammograms and confirmed as a benign in the further diagnostic images taken after at least two years from the screening mammograms. | Radiation: Mammography<br>* FFDM (Full-Field Digital mammography)<br>|
| Non-cancer<br>Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy. | Radiation: Mammography<br>* FFDM (Full-Field Digital mammography)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve | 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 | Through study completion, an average of 6 months |