Combining contrast enhanced mammography and radio-active free magnetic seed localization of non-palpable breast tumors: A feasibility study
Completed
- Conditions
- breast cancerbreast tumor1000629110006295
- Registration Number
- NL-OMON56142
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Women scheduled for breast conservative therapy for a non-palpable breast
lesion requiring image-guided localization using a magnetic seed.
Exclusion Criteria
Unable to provide written informed consent. Age <18 years. Pregnancy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study aim will be to test whether the magnetic seeds caused any<br /><br>disturbing artifacts on CEM images. For this purpose, two blinded radiologists<br /><br>will score the images for the presence of any artifacts and if present, if<br /><br>these are to such an extent that they would hamper diagnostic evaluation of the<br /><br>images. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary study, we will document technical success rate of seed deployment<br /><br>and retrieval during surgery, including the assessment of the surgical margins<br /><br>(positive or negative). </p><br>