Delphinus begins enrolment in whole-breast ultrasound device study
US-based medical imaging company Delphinus Medical Technologies has started patient enrolment for its SoftVue Discover Breast Ultrasound Prospective Case Collection project, which will compare its SoftVue breast ultrasound device with mammography.
SoftVue is a fast, fully automated and gentle system with a 360° ring transducer that studies the entire breast in a single pass by moving from the front to the chest wall.
Unlike conventional handheld ultrasound exams that can be time-consuming, SoftVue takes approximately two to four minutes per scan, while eliminating radiation exposure and compression.
The device is designed to highlight various tissue qualities that would allow radiologists to distinguish possible cancers from normal to benign findings.
With an enrolment of 10,000 asymptomatic women with dense breast tissue at various US centres, the project will screen the participants using both digital mammography and SoftVue 3D whole-breast ultrasound exams.
Delphinus Medical Technologies president and CEO Mark Forchette said: “Our company’s singular focus is to transform early detection of breast cancer with our breakthrough SoftVue imaging technology."
The Discover Breast Ultrasound project will enable the company to work with leading radiologists and breast cancer professionals to show the importance of its whole-breast ultrasound device that will have the capacity to detect the disease earlier, Forchette stated.
Data gathered during the project will be analysed to determine SoftVue's effectiveness in detecting cancers that could not be identified with mammography alone.
The data is expected to support the firm’s pre-marketing application (PMA) to the US Food and Drug Administration (FDA) for a supplemental screening indication of SoftVue in combination with mammography for women with dense breast tissue.