Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection
Breast Cancer, Resection Margin
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site) Solid tumor size ≥ 15 mm at screening, on sonography imaging Breast conserving surgery ≥ 18 years of age Ability to provide written informed consent Exclusion Criteria: Neoadjuvant chemotherapy Bilateral breast conserving surgery Invasive lobular carcinoma, DCIS, LCIS Suspicion of extensive DCIS component of NST tumor Diagnosis of recurrent breast cancer Previous radiotherapy Patient is pregnant or lactating Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation
Sites / Locations
- Department for Women's HealthRecruiting
Arms of the Study
Arm 1
Other
Intraoperative detection of light signals during electrosurgical breast cancer resection
Participants undergo electrosurgical breast cancer resection while light signals are detected intraoperatively