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

Completed

• Conditions: Carcinoma; 10006291; breast cancer

• Registration Number: NL-OMON42835
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-31
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

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

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;

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 BLES system, 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>- An analysis will be performed to identify predicting factors for<br /><br>underestimation and for complete excision of the lesion after BLES excision.<br /><br>Factors included in the analysis are patient related variables, lesion related<br /><br>variables, imaging features, surgical features and histopathological features<br /><br>from the core biopsy.<br /><br><br /><br>- When tumour margins of the biopsy specimen are positive and a residual (in<br /><br>situ) tumour in the surgical specimen is found, the agreement between<br /><br>histopathologic examination of biopsy specimen and surgical specimen can be<br /><br>assessed.</p><br>