Delphinus Medical Technologies Inc. in Novi has announced the results of a study comparing the use of whole breast ultrasound tomography and mammography to assess breast cancer risk. The company offers advanced breast ultrasound technology.
The study was conducted by researchers at the National Cancer Institute, which is part of the National Institutes of Health, the Barbara Ann Karmanos Cancer Institute in Detroit, Wayne State University in Detroit, Henry Ford Health System in Detroit, The Mayo Clinic in Minnesota, and The George Washington University in Washington, D.C. It was published in the Journal of Clinical Medicine and supported by a contract from the National Cancer Institute.
“It is well-established that dense breast tissue is a breast cancer risk factor,” says Dr. Rachel Brem, director of breast imaging and intervention at The George Washington University and the program leader of breast cancer at The George Washington Cancer Center. “This study suggests that whole breast ultrasound tomography may provide stronger and more specific information about that risk than mammography, which may ultimately help to stratify the risk in order to suggest more personalized screening and interventions. We are encouraged by the study results that indicate the potential use of whole breast ultrasound to improve the accuracy of breast cancer risk assessment with a non-ionizing breast imaging modality.”
Mammographic percent density is an independent risk factor for developing breast cancer. It only modestly improves breast cancer risk prediction and is not typically assessed in women under 40 because of ionizing radiation concerns. Previous studies have shown that tissue sound speed, derived from ultrasound tomography, is a potential surrogate marker of breast density, but prior to this study, sound speed had not been directly linked to breast cancer risk.
The study evaluated the relationship of sound speed using Delphinus’ SoftVue 3D whole breast ultrasound system as well as mammographic percent density with breast cancer risk in a case-control study. It compared 61 patients with a recent breast cancer diagnosis with 165 women with no person history of breast cancer.
The study demonstrated that increasing quartiles of whole breast volume-averaged sound speed were consistently and more strongly associated with increasing breast cancer risk than quartiles of mammographic percent density. The findings were statistically significant and suggest future opportunities for using ultrasound tomography breast cancer risk assessment, particularly in younger women with the absence of ionizing radiation.
“This study expands the potential application of our platform SoftVue technology beyond diagnostic imaging and breast cancer screening to cancer risk stratification for women at virtually any age, including the approximately 70 million women in the U.S. that are below screening age,” says Dr. Neb Duric, chief technology officer at Delphinus. “We believe that SoftVue imaging may enable individual risk assessment and intervention at an early age, when interventions are the most effective, as well as personalized screening regimens that take into account risk levels.”
Delphinus’ SoftVue has received sequential U.S. Food and Drug Administration clearances. The technology delivers no radiation, requires no compression, and images the entire breast with a single scan.