MaMaLoc: A study on the use of a magnetic marker for tumor localization in breast cancer surgery.
- Conditions
- mamma carcinoma, tumor localization, usability, patient outcome, innovation<br />borstkanker, tumorlokalisatie, gebruiksgemak, patientuitkomsten, innovatie
- Registration Number
- NL-OMON23005
- Lead Sponsor
- Antoni van Leeuwenhoek, NKI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
breast cancer patients
aged ≥18 years
Exclusion Criteria
Patients scheduled for an MRI scan in the period between marker placement and surgery
(Expected) time between placement of magnetic marker and surgery ˃ 30 day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical usability, (defined as the general System Usability Scale (SUS)
- Secondary Outcome Measures
Name Time Method •Surgical convenience (questionnaire and RTA)<br /><br>•Radiologist satisfaction (SUS)<br /><br>•Patient reported pain (VAS)<br /><br>•Patient convenience of the technique (Likert scale)<br /><br>•Clinical parameters<br /><br>•Success rate of localization procedure<br /><br>•Resection margin status <br /><br>•Operation time<br /><br>•Re-operation rate <br /><br>•Specimen weight and volume <br /><br>•Marker migration (intervention group subset, max N=10)<br /><br>•Learning curve for the MaMaLoc localization technique. <br>