ABSTRACT
OBJECTIVE: To assess the sensitivity, specificity and safety of dynamic optical breast imaging (DOBI) and mammography according to the pathological results. METHODS: From June 2005 to January 2006, 62 patients in Peking University People's Hospital and Capital Medical University Affiliated ChaoYang Hospital who received mammography and needed biopsy were enrolled prospectively, signed the consent form and recorded the comfortable level, acceptability and any complications during DOBI examination. Images obtained with DOBI and mammography were evaluated by 3 independent doctors who didn't know the pathological results to calculate the breast cancer diagnostic sensitivity and specificity. RESULTS: In this study the sensitivity and specificity of breast cancer diagnosis by mammography were 0.935 5±0.044 1 (95%CI 0.709 2-0.968 2)and 0.451 6±0.089 4 (95%CI 0.276 4-0.626 8)respectively. The sensitivity and specificity of DOBI were 0.838 7±0.066 1 (95%CI 0.709 2-0.968 2)and 0.612 9±0.087 5 (95%CI 0.441 4-0.784 4)respectively. In the DOBI examination there was no adverse reaction. The tolerability of DOBI was good. CONCLUSION: Dynamic optical breast imaging could provide the functional information about angiogenesis on the lesion and improve the breast cancer diagnostic specificity. It is a potential non-invasive breast functional imaging diagnostic tool and needs more large scale clinical trial to determine its indications and diagnostic criteria.
