Minimal invasive breast cancer excision using vacuum assisted biopsy under ultrasound guidance

Recruiting

Conditions: breast cancer
Carcinoma
10006291

Registration Number: NL-OMON52555

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

1. Female sex.
2. 18 years or older.
3. US visible breast cancer.
4. Histologically proven non-lobular invasive breast carcinoma with maximum
diameter of 15 mm as assessed by US.
5. Willing and able to undergo preoperative breast MRI
6. Able to fill out the questionnaire
7. Able to provide informed consent.

Exclusion Criteria

1. Male sex.
2. 17 years or younger.
3. No proven invasive breast cancer.
4. Poor US visibility of the breast cancer.
5. Neoadjuvant therapy.
6. Contra-indications to breast MRI or intravenous contrast administration.
7. Unable to fill out the questionnaire
8. Unable to provide informed consent.
9. Patients with breast implants.
10. Pregnancy.
11. Presence of ipsilateral lesions on MRI.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is the frequency of successful complete tumour<br /><br>excision by the VAB, where successful is defined as *having tumour free<br /><br>margins, and no residual (in situ) cancer in the surgical specimen'.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Whether we can predict successful complete resection of the tumor based on<br /><br>imaging features other than size.<br /><br>- Whether we can predict successful complete resection of the tumor based upon<br /><br>histopathological features from the large core biopsy specimens.<br /><br>- To analyze the characteristics of eventual residual tumor deposits in the<br /><br>surgical specimens.<br /><br>- To explore SN status following VAB of the primary tumor.<br /><br>- Analyze the difference in quality-of-life and pain experience between VAB<br /><br>excision and surgery.</p><br>