Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
Radboud University Medical Center
170 participants
Aug 2, 2021
INTERVENTIONAL
Conditions
Summary
This study will assess whether it is feasible to remove small breast cancers completely using the Vacuum Assisted Biopsy (VAB) system System under Ultrasound guidance.
Eligibility
Inclusion Criteria7
- Female sex.
- years or older.
- US visible breast cancer.
- Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US.
- Willing and able to undergo preoperative breast MRI
- Able to fill out the questionnaire
- Able to provide informed consent.
Exclusion Criteria11
- Male sex.
- years or younger.
- No proven invasive breast cancer.
- Poor US visibility of the breast cancer.
- Neoadjuvant therapy.
- Contra-indications to breast MRI or intravenous contrast administration.
- Unable to fill out the questionnaire
- Unable to provide informed consent.
- Patients with breast implants.
- Pregnancy.
- Presence of additional malignant lesions at ipsilateral site on MRI.
Interventions
First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (\<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location.
After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04107636