September 27, 2016 -- Breast imaging developer Seno Medical Instruments announced interim results from its MAESTRO study at last week's European Society of Breast Imaging (EUSOBI) meeting in Paris.
The results from the study demonstrate the potential of the company's Imagio optoacoustic (OA) breast imaging system to determine whether a suspicious mass is cancerous, with the goal of reducing the rate of negative biopsies, according to the vendor. The system, which received its CE Mark in 2014, has the potential to reduce negative biopsies by 43%, the firm said.
MAESTRO, a controlled, multicenter, observational, postmarketing surveillance and clinical follow-up study, was designed to assess the specificity and sensitivity of optoacoustics to conventional diagnostic ultrasound in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed ultrasound to reach a diagnosis and decision to biopsy followed by an Imagio OA examination. The study enrolled 200 women with undiagnosed suspicious masses.
The interim analysis of 78 subjects found that, following the use of Imagio system, radiologists downgraded BI-RADS categories of the internal ultrasound control-classified BI-RADS 4a masses to BI-RADS 3 or 2 in 75% of cases, and they downgraded BI-RADS 4b masses to either BI-RADS 3 or 2 in 37.5% of cases. The interim results also showed that Imagio OA increased specificity to more than 43%, with no significant loss in sensitivity. In addition, clinicians were able to reduce the rate of false-positive diagnoses by 20% for the last 48 subjects evaluated in the study.
Final results from the MAESTRO study are expected to be announced in early 2017. Enrollment for a U.S. trial of more than 2,000 patients has been completed and results will be announced in the latter half of 2017, according to the company.
The firm is planning to file its premarket approval submission for the Imagio system to the U.S. Food and Drug Administration by the end of 2016.