breast cancer Mamma calcifications
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Women 50 to 75 years old - Recalled from screening due to calcifications - Planned to go for stereotactic biopsy
Exclusion criteria
Exclusion criteria: - Women with prior breast cancer - Women who are very frail and unable to cooperate - Women who cannot give informed consent - Contraindication of iodine contrast (i.e., contrast allergy, renal function impairment (GFR >=60 mL/min/1.73m2)) - Contraindication for irradiation (i.e., genetic mutation that predispose to breast cancer) - Male subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the prevention of unnecessary biopsies and the non-invasive distinction between low grade (indolent) ductal carcinoma in situ (DCIS), and higher grade (potentially lethal) disease. In particular, prevention of the unnecessary biopsies will be a justified alternative solution, depending on the sensitivity of CEBCT for DCIS when focal enhancement around calcifications is deemed positive and no enhancement is regarded as a negative test outcome. In order to propose such a follow-up process instead of the stereotactic biopsy, reliable and high-performance metrics are needed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. the frequency of enhancement on CEBCT near calcifications with a benign origin In order to calculate the frequency rate of enhanced areas on CEBCT near calcifications, the gold standard of histopathological verification is needed to identify their benign origin. 2. the association between enhancement patterns and histological grade of the disease Since the amount of enhancement is related to the aggressiveness of DCIS, we infer that signal intensities in CEBCT will also reflect biological aggressiveness. | — |
Countries
Netherlands
Outcome results
None listed