A study has shown that Delphinus Medical Technology’s SoftVue breast ultrasound tomography (UST) system demonstrates superiority in cancer detection compared to mammography alone in women with dense breasts.
The study published in the Radiology journal, involved 32 radiologists following 140 cases. Levels of density are described using the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS). The radiologists assessed the mammogram, assigned a BI-RADS score, and then assessed the mammogram plus UST for the same case and did a separate BI-RADS assessment.
Data demonstrated that integrating SoftVue UST with screening mammography significantly improved breast cancer detection in women with dense breasts. Specifically, the combination increased sensitivity for detecting BI-RADS 4 or higher lesions by 25% and improved specificity for BI-RADS 3 lesions by 8%, compared to mammography alone.
SoftVue – which received premarket approval (PMA) from the US Food and Drug Administration (FDA) in October 2021 – is a 3D whole breast UST system developed specifically for dense breast cancer screening in addition to mammography.
The system is fully automated with a 360° ring transducer that studies the entire breast in a single pass by moving from the front to the chest wall. It utilises sound and water instead of radiation, taking between two to four minutes for each breast.
Headquartered in Novi, Michigan, Delphinus claims to be the first company to design and manufacture a 3D ultrasound system that images the breast using sound and water.
The benchmark of breast cancer screening, mammography uses X-rays to find and locate breast tumours. Detecting issues in dense breast tissue, which has more glandular and fibrous components compared to fat, is more challenging. This can result in small tumours being missed and delaying cancer diagnosis.
While any woman can have dense breasts, it is associated with younger women, a lower body mass index, and women who take combination hormone therapy to relieve menopause symptoms.
Delphinus’ medical director Elise Berman said: “SoftVue provides a unique solution that has been missing in dense breast screening. As a breast imager, it is exciting to see a screening technology that not only increases cancer detection but also allows us to reduce the number of short-term follow-ups.
“This means more women who have breast cancer will be referred for biopsy immediately and more women without breast cancer will be reassured they do not need follow-up.”
In April 2024, QT Imaging Holdings revealed positive data demonstrating that its Breast Acoustic CT scan imaging technique can be used as a potential alternative to mammography for breast cancer screening of women with dense breasts.
