Magnetic Marker Localization for breast cancer surgery: An exploratory study

Completed

Conditions: breast cancer
breast carcinoma
10006291
10006295

Registration Number: NL-OMON44563

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

*breast cancer patient
*scheduled for breast conserving surgery with localization
*aged >=18 years
*unifocal tumor
*good ultrasound visibility

Exclusion Criteria

* Planned MRI in the period between marker placement and surgery
* (Expected) time between placement of magnetic marker and surgery * 30 day
* Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ease of use surgeon (System Usability Scale)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Radiologist satisfaction (SUS) * Retrospective think aloud for surgeon and<br /><br>radiologist after procedure * Tumor-depth on ultrasound and mammography, in mm<br /><br>(skin to lesion) * Surgeon convenience (specific questionnaire) * Operative<br /><br>time in minutes * Delay in OR sheculding/start as a consequence of the<br /><br>localization technology (in minutes) * Intervention only: learning curve<br /><br>assessment * Intervention only: marker migration * Success percentage: no<br /><br>fall-back to ultrasound needed * Specimen weight (g), size (mm), volume (cc) <br /><br>Dominant tumor size (in mm) Resection margin status * Histopathological data<br /><br>* Patient reported pain (VAS) * Patien reported convenience (likert)</p><br>