Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer

SURGYPET: Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology: a Prospective Non-inferiority Analysis

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• active bacterial, viral or fungal infection.