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Completed
NCT05615298
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
Conditions: Breast Cancer
Sex: Female
Healthy volunteers: 1
Enrollment: 240
Sponsor: Lunit Inc.
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:FemaleAny ethnic originAcquired with devices from two manufacturers: Hologic and GE4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)Exclusion Criteria:Previous core needle biopsy in breast for past 2 yearsPrevious vacuum-assisted biopsy, surgical biopsy or surgery in breastPrevious breast cancerLactating when taking screening mammogramsPresence of a breast implant in screening mammogramsPresence of a pacemaker in screening mammogramsInadequate quality status such as insufficient anatomical coverage of screening mammograms
Source: ClinicalTrials.gov (NCT05615298). StuddyBuddy aggregates publicly available trial information.
