5. DIAGNOSTIC ACCURACY OF EX-VIVO FUSION CONFOCAL MICROSCOPY IN BREAST CANCER

Abstract

Abstract Introduction Ex-Vivo fusion confocal microscopy (EVFCM) provides a fast examination of breast tissues with the potential to reduce the rate of positive surgical margins and the need for additional interventions. This is an observational study aimed at verifying the diagnostic accuracy of EVFCM in diagnosing neoplasia and histologic subtypes. Methods Thirty-six breast tissue samples, including non-neoplastic (n=20) and neoplastic (n=16), underwent scanning using EVFCM. These samples were also processed through routine histopathological examination with hematoxylin and eosin, and the two techniques were subsequently compared. The assessment was performed by a Mohs surgeon dermatologist familiar with EVFCM (evaluator A) and two breast pathology experts (evaluators B and C) without experience in EVFCM, in a blinded diagnosis analysis. Results The ability to recognize neoplasia in the EVFCM images obtained a high level of concordance, as indicated by all kappa values (κ) presenting a p-value <0.001. Investigator A demonstrated a sensitivity and specificity of 100% in diagnosing neoplasia. Evaluators B and C exhibited a sensitivity >87% and a specificity >94% in diagnosing neoplasia, with positive predictive values (PPV)>95% and the negative predictive values (NPV) of 81% and 94%, respectively. The accuracy in recognizing the histological subtype was >86,1%, with a sensitivity >82%, specificity >88%, PPV>75% and NPV>92%. Conclusion EVFCM demonstrates excellent diagnostic accuracy for breast cancer, with high levels of concordance, sensitivity and specificity. Based on our data, we suggest and propose that EVFCM will be an excellent tool for intra-operative and definitive margin assessment, guiding breast conserving surgeries.