CMOS Technology for Intraoperative Digital Imaging Can the Re-excision Rate after Breast Surgery be Reduced?

Purpose: A retrospective clinical study was done to investigate whether a new intraoperative digital imaging system (BioVision (TM)) could reduce the rate of re-excisions compared to a commercial FFDM system. Material and Method: Between 12/2010 and 2/2011 we diagnosed an invasive breast cancer (BI-RADS (TM) 5) in 100 patients. After histological verification we performed breast-conserving therapy with intraoperative imaging. After surgery, all specimens were re-examined radiologically with: 1) BioVision (TM) (Bioptics (TM), Tucson, USA), photo-diode array flat panel, tungsten source, focus 0.05, resolution 50 mu m, 12 lp/mm; 2) Inspiration (TM) (Siemens (TM), Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1 mm, resolution 85 mu m, 8 lp/mm. The 600 images of the operated specimens were randomly encoded (random generator) and shown on a monitor to five investigators with different levels of experience in mammography. Results: At a magnification of 1:1, our findings for the two systems (BioVision (TM) and Inspiration (TM)) arrived at the same results and these were in accordance with the final histology, i.e. no re-excision was necessary in 79 of the 100 patients. The retrospective randomly encoded analysis (n = 21) demonstrated a significant (p < 0.05) increase in sensitivity of the BioVision (TM) system compared to the Inspiration (TM) of 1% at a magnification of 1.4:1.0 or 1.5:1.0 respectively, and of 2.4% at a magnification of 2: 1 or 1.8:1.0 respectively. This means that with the new intraoperative imaging system a re-excision would not have been necessary in 1 or 3 patients, respectively. Conclusion: The new digital intraoperative imaging system BioVision (TM) has a significantly (p < 0.05) increased sensitivity compared to a commercial FFDM system.