Breast cancer Suspected Breast Lesions
Conditions
Interventions
The procedure will take place under standard conditions in the department of
Radiology using the stereotactic guided HOLOGIC Affirm® Prone biopsy system and
HOLOGIC Suros vacuum console. The biopsy
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Woman (and trans man without mastectomy), >= 18 years old Patients with a suspected breast lesion on imaging that requires stereotactic diagnostic biopsy Written informed consent
Exclusion criteria
Exclusion criteria: Patients with breast implants History of breast-related radiotherapy treatment Previous breast surgery Suspected oversensitivity to light; e.g. patient who has had photodynamic therapy Pregnant and nursing patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the performance of DRS measurements for malignant (invasive carcinoma and DCIS) tissue type discrimination during a stereotactic breast biopsy. The main study endpoint is to achieve a sensitivity higher than 90% of our previous developed tissue classification algorithm in the detection of malignant (invasive carcinoma and DCIS) tissue types during a biopsy procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the added value of DRS measurements during a stereotactic biopsy procedure i.e. predict which biopsies are the most important for correct diagnosis (based on the results of the tissue sensing device). If we can predict which biopsies are the most important then in the future we can reduce the number of biopsies during the stereotactic biopsy procedure. | — |
Countries
Netherlands
Outcome results
None listed