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.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
