onradioactive surgical guidance with radiofrequency identification technology for locating nonpalpable breast lesions
Recruiting
- Conditions
- Breast cancer
- Registration Number
- NL-OMON22145
- Lead Sponsor
- Hologic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
In order to be eligible to participate in the cohort study, a subject must meet all of the following inclusion criteria:
? 1. Female patient = 18 years of age
? 2. Nonpalpable histologically proven in situ or invasive breast cancer that requires excision
? 3. Patient is scheduled for breast conserving surgery
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in the cohort study:
? 1. Breast lesion is located deeper than 7 cm from the skin when lying supine
? 2. Multicentric breast cancer
? 3. Pregnancy or lactating
? 4. Subject is unable to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to her
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the percentage radical excisions. Margins are classified as tumor free, focally irradical and (more than focally) irradical, see figure below. Both focally irradical and more than focally irradical excisons are considered irradical excisions. The percentage of re-excisions following irradical excisions is recorded.
- Secondary Outcome Measures
Name Time Method - Successful placement of the RFID tag<br>- Duration of placement procedure<br>- Ease of placement procedure<br>- Pain score of the patient during placement<br>- Successful retrieval of the RFID tag<br>- Duration of surgical procedure<br>- Ease of surgical procedure<br>- Volume of resection specimen vs volume of tumor<br>- RFID tag migration<br>- Post-operative wound infection<br>- Learning curve radiologist/surgeon