Seno Medical reports positive interim data from Maestro study of breast imaging system
US-based medical imaging company Seno Medical has reported positive interim results from its MAESTRO study of Imagio opto-acoustic (OA) a breast imaging system used to detect breast cancer.
The Imagio system has been developed to allow physicians to determine whether a suspicious mass detected in the breast is cancerous, resulting in a reduction in the rate of negative biopsies.
It uses a light-in and sound-out technology with diagnostic ultrasound (OA / US).
The Imagio OA / US breast imaging system provides real-time images of the vast network of blood vessels and a map of relative oxygen-rich or oxygen-depleted blood surrounding the tumour.
It does not use x-rays or injectable contrast agents or radio-isotopes to get its information, eliminating the need for the patient to be exposed to potentially harmful aspects of imaging.
The Maestro trial has been designed as a controlled, multi-centre, observational, post-market surveillance and clinical follow-up study, aimed at evaluating the specificity and sensitivity of Opto-Acoustics to conventional diagnostic ultrasound (CDU) in identifying suspicious masses classified as BI-RADS 4a and 4b.
The investigators conducted a CDU to reach diagnosis, following which they conducted an examination using the Imagio OA.
The study involved 200 female patients with undiagnosed suspicious breast masses.
An interim analysis of 78 patients suggested the efficacy of the instrument in enabling the radiologists downgrading BI-RADS categories of the internal ultrasound control-classified BI-RADS 4a masses to BI-RADS 3 or 2 in 75% of cases, and BI-RADS 4b masses to either BI-RADS 3 or 2 in 37.5% of cases.
Imagio OA has also demonstrated an increased specificity without any significant compromise on sensitivity. The clinicians were also able to decrease the rate of false-positive diagnoses while analysing the last 48 patients.
Seno Medical Instruments CEO Tom Umbel said: "The interim results of the MAESTRO study are promising and could help physicians reliably and safely assess suspicious masses to deliver optimal treatment for each patient.”
The final result of the study is expected to be announced at the end of next year.