Status:
RECRUITING
Minimal Invasive Breast Cancer Excision Using Vacuum Assisted Biopsy Under Ultrasound Guidance
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Canisius-Wilhelmina Hospital
The Netherlands Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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.
Detailed Description
Rationale: In the Netherlands, ≥7000 women undergo surgery for small breast cancers (T1) every year. In this study, the investigators will evaluate under which conditions it is possible to excise smal...
Eligibility Criteria
Inclusion
- Female sex.
- 18 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
- Male sex.
- 17 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.
Key Trial Info
Start Date :
August 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04107636
Start Date
August 2 2021
End Date
December 1 2025
Last Update
July 25 2025
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB