The rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen PET/CT imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during Breast Cancer Surgery (BCS) as compared to standard-of-care gross pathology evaluation.
The PET/CT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
females with an age over 18 years;
confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension);
vacuum-assisted core breast biopsy is allowed for non-invasive tumors only;
able to understand treatment protocol and informed consent form;
estimated by the investigator to be compliant for study participation.
You may not be if
general or local contra-indication for BCS;
previous breast surgery;
inflammatory breast cancer;
radiotherapy of the ipsilateral breast;
vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm);
pregnancy or lactation;
participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year;
