breast cancer Carcinoma
Conditions
Interventions
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in the study: 1. Female sex; 2. 19 years or older; 3. US visible breast cancer; 4. Histologically proven invasive breast cancer with maximum diameter of 15 mm as assessed by US; 5. Willing and able to undergo preoperative breast MRI; 6. Able to undergo diathermic breast lesion excision; 7. Able to provide informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Male sex; 2. 18 years or younger; 3. No proven invasive breast cancer; 4. Poor US visibility of the breast cancer; 5. Breast cancer closer than 6 mm to the skin, nipple or pectoral muscle; 6. Contra-indications to breast MRI or intravenous contrast administration; 7. Contra-indications for the use of diathermia; 8. Unable to provide informed consent; 9. Patients with breast implants; 10. Patients with implanted electronics; 11. Pregnancy. 12. Neoadjuvant therapy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of this study is the frequency of successful complete tumour excision by the BLES system, where successful is defined as *having tumour free margins, and no residual (in situ) cancer in the surgical specimen'. | — |
Secondary
| Measure | Time frame |
|---|---|
| - An analysis will be performed to identify predicting factors for underestimation and for complete excision of the lesion after BLES excision. Factors included in the analysis are patient related variables, lesion related variables, imaging features, surgical features and histopathological features from the core biopsy. - When tumour margins of the biopsy specimen are positive and a residual (in situ) tumour in the surgical specimen is found, the agreement between histopathologic examination of biopsy specimen and surgical specimen can be assessed. | — |
Countries
The Netherlands
Outcome results
None listed