Ultrasound technology developer QT Ultrasound said that its transmission ultrasound system yielded higher diagnostic performance than full-field digital mammography (FFDM) in the first-in-human study of the technology for breast cancer screening.
In a study published online December 3 in Academic Radiology, researchers from QT Ultrasound reported that its 3D quantitative transmission ultrasound technology provided better sensitivity and specificity, as well as lower recall rates. The research encompassed two clinical trials performed at five sites and involving 22 radiologists and 108 female subjects who received FFDM and transmission ultrasound exams within a 90-day period, QT said.
In the retrospective analysis, transmission ultrasound produced a 4% increase in sensitivity and a 16% increase in specificity, according to the company. QT said it would use the findings from this study and additional studies to gain FDA clearance under its FDA breakthrough device designation for screening younger at-risk women.
In addition, a prospective study comparing 3D transmission ultrasound to digital breast tomosynthesis is now warranted and will be published in the future, QT said.