Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Objectives: 1) To establish the non-inferiority of the diagnostic accuracy of the Planmed
Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film
mammography (SFM) in the detection of breast cancer; and 2) To demonstrate in a comparative
side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM
X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer
Approximately one year after completion of study.
Sami Tohka, PhD
United States: Institutional Review Board
|Mroz-Baier Breast Care Clinic||Memphis, Tennessee 38119|
|The Rose||Houston, Texas 77034|