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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05615298

Run by

Lunit Inc.

People needed

240

Starts

2020-06-15

Expected to finish

2021-01-13

Last updated by the study team

2022-11-14

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Atrius Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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