Minimal invasive breast cancer excision using the breast lesion excision system under ultrasound guidance - a feasibility study - BLES

Radboud Universitair Medisch Centrum0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

Trial ended prematurely

•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.

•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;

发起方