Breast cancer
Conditions
Interventions
None listed
Sponsors
Hologic
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - Successful placement of the RFID tag - Duration of placement procedure - Ease of placement procedure - Pain score of the patient during placement - Successful retrieval of the RFID tag - Duration of surgical procedure - Ease of surgical procedure - Volume of resection specimen vs volume of tumor - RFID tag migration - Post-operative wound infection - Learning curve radiologist/surgeon | — |
Contacts
Public ContactBianca Marina den Dekker
University Medical Center Utrecht
Outcome results
None listed