Mammography / Mammografie Tomosynthesis / Tomosynthese Compression / Aandrukking Breast / Borst Diagnosis / Diagnose
Conditions
Interventions
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
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. unable to understand the patient information folder 2. has or previously had breast endo-prostheses (implants) 3. underwent any form of breast surgery or therapy, with the exception of Breast Conserving Therapy with radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to identify which level of contact-pressure (6, 8, 10 or 12 kPa) is optimal, the investigators team defines a weighed sum of the three output measures: Compression Score =2 * Lesion Conspicuity Score (3 rater average: ¨C8 to +6 scale) ¨C1 * Relative Dose Score (relative AGD difference: ¨C5 to +5 scale) ¨C1 * 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactJ. Stoker
Postbus 22660
Outcome results
None listed