What’s the best way to provide supplemental imaging when screening women with dense breasts? A new study this week in Radiology offers support for a newer method, whole-breast ultrasound tomography.
It’s well-known by now that dense breast tissue presents challenges to traditional X-ray-based mammography.
- In fact, mammography screening’s mortality reduction is far lower in women with dense breasts compared to nondense breasts (13% vs. 41%).
A variety of alternative technologies have been developed to provide supplemental imaging for women with dense breasts, from handheld ultrasound to breast MRI to molecular breast imaging.
- One supplemental technology is whole-breast tomography, developed by Delphinus Medical Technologies; the firm’s SoftVue 3D system was approved by the FDA in 2021 as an adjunct to full-field digital mammography for screening women with dense breast tissue.
With SoftVue, women lie prone on a table with the breast stabilized in a water-filled chamber that provides coupling of sound energy between the breast and a ring transducer that scans the entire breast in 2-4 minutes.
- Unlike handheld ultrasound, the scanner provides volumetric coronal images that provide a better view of the fat-glandular interface, where many cancers are located.
SoftVue’s performance was analyzed by researchers from USC and the University of Chicago in a retrospective study funded by Delphinus.
- They performed SoftVue scans along with digital mammography on 140 women with dense breast tissue from 2017 to 2019; 36 of the women were eventually diagnosed with cancer.
In all, 32 readers interpreted the scans, comparing the performance of FFDM with ultrasound tomography to FFDM alone, finding …
- Better performance with FFDM + ultrasound tomography (AUC=0.60 vs. 0.54)
- An increase in sensitivity in women with mammograms graded as BI-RADS 4 (suspicious), (37% vs. 30%)
- No statistically significant difference in sensitivity in BI-RADS 3 cases (probably benign), (40% vs. 33%, p=0.08)
- A mean of 3.3 more true-positive and 0.9 false-negative findings per reader with ultrasound tomography, a net gain of 2.4
The Takeaway
The findings indicate that ultrasound tomography could become a new supplementary tool for imaging women with dense breasts. They are also a shot in the arm for Delphinus, which as a smaller vendor has the challenge of competing with large multinational OEMs that also offer technologies for supplemental breast screening.
