Breast cancer Intraoperative Margin Assessment using specimen PET-CT (BIMAP)

Positive surgical margins in breast-conserving surgery (BCS) for breast cancer occur in 20% of cases, making intraoperative margin assessment (IMA) crucial to avoid re-operations. This study evaluated specimen PET-CT imaging for IMA in 41 patients undergoing BCS. Specimen PET-CT imaging was performed with the ß-CUBE/X-CUBE (MOLECUBES) or the AURA 10 (XEOS). Seven physicians, with varying experience, assessed margin status postoperatively as positive, close (≤1 mm), or negative using PET-CT images at 10 min acquisition time and low reconstructed [¹⁸F]FDG dose (0.8MBq/kg). Close margins on PET-CT were analyzed once as positive and once as negative. Histopathology was the gold standard. The proposed technique showed 91% sensitivity and 86% specificity for invasive ductal carcinoma (IDC). Histopathology identified 9 positive margins in 31 IDC cases; 88% were detected by all physicians on specimen PET-CT whereas standard of care identified 44%. Therefore, specimen PET-CT will improve IMA in BCS and potentially reduce re-operation rates. The trial is registered since 20/01/2020 on ClinicalTrials.gov (ID: NCT04343079) with the title: "Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer".