Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates

Accuracy Based on Pathology Results

Malignant pathologic results will be used to determine Accuracy (True Positive\[Sensitivity\], True Negative \[Specificity\], Positive and Negative Predictive values\[PPV,NPV\]) of FFDM and limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) \[Groups A and B\]. A Positive screening read had an overall site recommendation of additional Workup A Positive diagnostic read is defined as either Breast having a BIRADs score of 4 or 5 on the diagnostic read (where high BIRADS indicates higher confidence of malignancy)

Time frame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)

Accuracy, Based on Pathology Results, by Lesion Classification

Malignancy determined by pathology and follow-up will be used to determine Accuracy (True Positive\[Sensitivity\], True Negative \[Specificity\], Positive and Negative Predictive values\[PPV,NPV\]) of FFDM and limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) with results reported by lesion-type characterization (calcification-only lesions versus soft-tissue lesions,)\[Groups A and B\]. A Positive screening read had an overall site recommendation of additional screening A Positive diagnostic read is defined as either Breast having a BIRADs score of 4 or 5 on the diagnostic read.

Time frame: at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)

Callback Rate of Two-view Limited Tomosynthesis Set (With Low-dose MLO View Alone) With the Tomosynthesis Plus Set (Low-dose MLO View Plus Addition of Low-dose CC View)

Sequential interpretation results for call- back from two-view limited tomosynthesis set (with low-dose MLO view alone) and tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view)

Time frame: At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure)

Radiation Dose

Radiation dose by modality (FFDM \& DBT2D/3D) Dose obtained from the data contained in the acquisition DICOM headers.

Time frame: at the first imaging session

Regression Model Parameters for Factors Effecting Radiation Dose

a mixed Regression Model to identify the determinants of participant radiation dose, including covariates (X) such as: kVp, mAs, target/filter combination, and breast thickness and compression. Dose = B1\*X1 + B2\*X2 + B3\*X3 + ... The outcome measures is are the estimated coefficients (B) of the covariate (X) in the mixed regression model. The coefficient (B) of the term (X) represents the change in the mean response (dose) for one unit of change in that term. If the coefficient is negative, as the term increases, the mean value of the response decreases. If the coefficient is positive, as the term increases, the mean value of the response increases. Note: the TUNGSTEN/SILVER categorical target/filter combination is used as the reference category and will have a parameter value of 0.

Time frame: at the first imaging session

Identification and Characterization of Lesion(s) Using Screening Tomosynthesis (Group A)

Group A, screening tomosynthesis, cases will be evaluated using 2 methodologies. Readers will read each screening exams using either (1) the limited tomosynthesis set (with low-dose MLO view alone) or (2) the tomosynthesis plus set (low-dose MLO view plus addition of low-dose CC view) and classify the lesions they are able to visualize per SOC. SOC Lesions characterizations include: Calcification Only lesion , Mass, Focal Asymmetry, Architectural Distortion, Global Asymmetry, Calcification) The characterizations will be tabulated by whether or not each lesion was classified in the given category.

Time frame: At the Diagnostic workup (within 30 Days After Screening)