breast cancer breast carcinoma
Conditions
Interventions
Subjects will be randomly assigned to either the first (control) or second
(intervention) group by means of drawing an envelope. Wire Guided Localization
is the current standard of care. With the Ma
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *breast cancer patient *scheduled for breast conserving surgery with localization *aged >=18 years *unifocal tumor *good ultrasound visibility
Exclusion criteria
Exclusion criteria: * Planned MRI in the period between marker placement and surgery * (Expected) time between placement of magnetic marker and surgery * 30 day * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease of use surgeon (System Usability Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Radiologist satisfaction (SUS) * Retrospective think aloud for surgeon and radiologist after procedure * Tumor-depth on ultrasound and mammography, in mm (skin to lesion) * Surgeon convenience (specific questionnaire) * Operative time in minutes * Delay in OR sheculding/start as a consequence of the localization technology (in minutes) * Intervention only: learning curve assessment * Intervention only: marker migration * Success percentage: no fall-back to ultrasound needed * Specimen weight (g), size (mm), volume (cc) * Dominant tumor size (in mm) * Resection margin status * Histopathological data * Patient reported pain (VAS) * Patien reported convenience (likert) | — |
Countries
Netherlands
Outcome results
None listed