Comparison of intraoperative specimen radiography (IOSR) with or without KliniTray system in patients with breast conserving surgery of intraductal breast cancer
Not Applicable
- Conditions
- D05.1Intraductal carcinoma in situ
- Registration Number
- DRKS00011527
- Lead Sponsor
- niversitätsfrauenklinik am Klinikum Südstadt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
patient signed informed consent;
histologically proven intraductal carcinoma with microcalcifications (inclusive early invasive breast cancer);
planned breast-conserving surgery;
age >/= 18 years
Exclusion Criteria
no microcalcifications;
recent surgery for diagnostic purpose
planned mastectomy
age<18
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the pathological free margin (minimal pathological resection margin >/= 2 mm)
- Secondary Outcome Measures
Name Time Method effiency of immediate re-excision in case of radiological margins <5 mm to reach pathological free margins; <br>agreement of orientation of minimal radiological and pathological margins;<br>evaluation of digital tomosynthesis for specimen radiography;<br>cost-benefit-analysis<br>