This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.
The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging.
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;
general or local contra-indication for BCS;
previous breast surgery;
inflammatory breast cancer;
radiotherapy of the ipsilateral breast;
European Institute of Oncology
Lead sponsor