At the San Antonio Breast Cancer Symposium (SABCS), optoacoustic imaging firm Seno Medical Instruments is lauding the results of two analyses of the firm's European MAESTRO postmarket surveillance study using its optoacoustic technology.
The multicenter controlled MAESTRO trial aimed to assess the diagnostic value of examining suspicious masses classified as BI-RADS 4A and 4B using Seno's Imagio optoacoustic breast imaging system. The study team first performed conventional ultrasound to reach a diagnosis and decision to biopsy, followed by an Imagio optoacoustic exam in 200 subjects with undiagnosed suspicious masses.
The first analysis assessed the correlation between optoacoustic imaging results and histologic data on breast masses and found a statistically significant correlation between the two. The histopathological examination showed 146 benign masses and 67 malignant masses. Five predetermined optoacoustic features, three internal features, and two external features were evaluated for each mass. Optoacoustic feature scores significantly differentiated between benign and malignant masses and appeared to correlate to histologic grade.
The second, interim analysis assessed the ability of optoacoustic imaging to accurately classify breast masses as benign or malignant compared to conventional ultrasound. Imaging downclassification and upclassification data showed that the Imagio system improved doctors' ability to accurately classify breast masses. Results were originally presented in September at the European Society of Breast Imaging (EUSOBI) annual meeting in Paris.
