The pilot study portion of Seno's PIONEER trial, titled A Pivotal Study of Imaging With Optoacoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound, demonstrated the potential of the Imagio system to more accurately classify benign breast masses compared with traditional ultrasound methods, according to the company.
Overall, Imagio's optoacoustic breast imaging system yielded 97.6% sensitivity and 44.4% specificity in the 100-subject pilot study, which was presented at the recent RSNA 2015 meeting in Chicago. The pilot study was conducted as the initial part of a larger U.S.-based, multicenter PIONEER study of more than 2,000 subjects that seeks to demonstrate the ability of the Imagio system to downgrade BI-RADS scores.
In the pilot study, seven independent breast radiologist readers and an expert radiologist trainer blindly assessed 102 masses from the pilot study cases using only Imagio optoacoustic images. Among these subjects, there were 75 biopsied masses (39 benign, 36 malignant).
Grayscale ultrasound images were taken with the Imagio system's conventional ultrasound technology immediately prior to the optoacoustic exam, and these images were designated as the internal ultrasound control. Later, the readers also assigned a BI-RADS score to these images, Seno said.
Using optoacoustic imaging, the readers downgraded conventional diagnostic ultrasound findings that were classified as BI-RADS 3 (probably benign) masses to BI-RADS 2 (benign) in 33% of cases. As for cases with BI-RADS scores 4a or 4b (in which a suspicious abnormality is discovered and a biopsy is recommended), readers were able to downgrade BI-RADS 4a masses to BI-RADS 2 or 3 in 53% of cases and BI-RADS 4b masses to BI-RADS 3 or 2 in 33% of cases, according to the company.
In addition, the readers downgraded BI-RADS categories of the internal ultrasound control-classified BI-RADS 3 masses to BI-RADS 2 in 43% of cases, BI-RADS 4a to either BI-RADS 3 or 2 in 43% of cases, and BI-RADS 4b masses to either BI-RADS 3 or 2 in 13% of cases, Seno said.
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