Optimal pressure for Digital Breast Tomosynthesis

INTERVENTION: The investigational product is a variation in the level of contact‐pressure during breast compression for Digital Breast Tomosynthesis. Instead of the normal DBT‐recording, participants in this study will receive a custom two‐in‐one DBT‐recording consisting of two x‐ray exposures at two levels of contact‐pressure. Following a specific randomization scheme, the technologist initially applies 6, 8, 10 or 12 kPa of contact‐pressure and makes the first DBT‐recording. Instead of automatically releasing the breast as normal, the technologist increases the compression to 8, 10, 12 or 14 kPa of contact‐pressure and makes the second DBT‐recording. Thus, two DBT‐image sets are obtained from the breast in the same position with a slight difference in compression level. The two‐in‐one DBT‐recording will take approximately twice as long (60 – 90 seconds) as a normal DBT‐recording (30 – 45 seconds). The technologist who performs the procedure will ask the participant to verbally rate her pain experience on a 0 – 10 Numerical Rating Scale both immediately after the first DBT‐recording (i.e. before applying more pressure), and immediately after the second DBT‐recording (i.e. when the breast is released). CONDITION: Mammography, Tomosynthesis ; ; PRIMARY OUTCOME: In order to identify which level of contact‐pressure (6, 8, 10, 12 or 14 kPa) is optimal, the investigators team defines a weighed sum of the three output measures: ; ; ; ; Compression Score = 2 * Lesion Conspicuity Score (3 rater average: –8 to +6 scale); ; – 1 * Relative Dose Score (relative AGD difference: –5 to +5 scale); ; – 1 * Clinical Pain Score (recoded NRS scores: 0 to +10 scale); ; ; ; The formula reflects the clinically relevant weights of the three interests as chosen by the investigators team: improving lesion conspicuity is rated twice as important as reducing (note the minus‐sign) absorbed glandular x‐ray dose and reducing the clinical pain score.; SECONDARY OUTCOME: The two‐in‐one DBT‐recording design is unique in providing two image sets of the same breast with slightly different compression level, which enables compression blinking and x‐ray elastography. In order to assess the diagnostic value of these techniques, a panel of five to ten radiologist will be asked for their opinion in two ways: clinical and subjective. ; INCLUSION CRITERIA: 1, female 2, older than 30 years of age 3. receives DBT as standard procedure or as indicated by the responsible radiologist on site