Introduction
Delphinus Medical Technologies, a pioneering company in medical imaging, has announced the results of a groundbreaking study on the efficacy of its SoftVue Breast Ultrasound Tomography (UST) system. This study compared the cancer detection rates of mammography alone versus mammography combined with SoftVue UST in women with dense breasts. Published in the peer-reviewed journal *Radiology*, the study reveals significant improvements in cancer detection when SoftVue UST is used alongside traditional mammography.
Overview of SoftVue Breast Ultrasound Tomography (UST)
SoftVue UST is an innovative breast imaging system designed to enhance cancer detection, especially in women with dense breast tissue. Dense breast tissue can obscure tumors on mammograms, making additional imaging techniques essential. SoftVue UST offers a solution by providing detailed ultrasound images that complement mammographic findings, leading to better detection rates and improved patient outcomes.
Study Details and Methodology
Participants and Methods
The study included 140 cases and involved 32 radiologists from various academic, private, and community-based practices. These radiologists, all qualified under the Mammography Quality Standards Act (MQSA), independently evaluated mammograms and then reassessed the same cases with the addition of SoftVue UST. Each case was assigned a Breast Imaging Reporting and Data System (BI-RADS) score based on the imaging results.
Results and Findings
The study demonstrated that adding UST to mammography significantly improves cancer detection rates in women with dense breasts. Key findings include:
– Superiority in Cancer Detection: Mammogram plus SoftVue UST showed statistically superior performance in detecting breast cancer compared to mammography alone.
– Improvement in Sensitivity: There was a 25% increase in sensitivity for detecting BI-RADS 4 or higher lesions.
– Improvement in Specificity: There was an 8% increase in specificity for BI-RADS 3 lesions, allowing for better differentiation between benign and malignant masses.
Expert Opinions
Insights from Dr. Mary Yamashita
Dr. Mary Yamashita, Section Chief of Breast Imaging and Clinical Professor of Radiology and Surgery at the University of Southern California’s Keck School of Medicine, highlighted the significance of the study’s findings. She emphasized that the enhanced specificity provided by SoftVue UST helps radiologists differentiate benign masses from malignant ones, reducing unnecessary follow-ups and enhancing patient care.
Comments from Dr. Elise Berman
Dr. Elise Berman, Medical Director at Delphinus Medical Technologies, expressed her excitement about the potential of SoftVue UST in dense breast screening. She noted that the system not only increases cancer detection rates but also reduces the number of short-term follow-ups, offering reassurance to women without breast cancer and ensuring prompt biopsies for those who need them.
Impact on Breast Cancer Screening
Breast cancer screening with mammography is known to reduce mortality rates significantly. However, the effectiveness is diminished in women with dense breasts. SoftVue UST offers a much-needed supplemental screening tool that can enhance cancer detection and improve outcomes for this group. The U.S. government’s mandate for federal breast density notifications, effective September 2024, underscores the importance of such advancements in screening technology.
Conclusion
The study published in *Radiology* marks a significant milestone in breast cancer screening. By combining SoftVue UST with traditional mammography, radiologists can achieve higher detection rates and better specificity, particularly in women with dense breast tissue. This advancement holds promise for improving early detection and reducing breast cancer mortality.
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Frequently Asked Questions (FAQs)
Q1: What is SoftVue Breast Ultrasound Tomography (UST)?
SoftVue UST is an advanced ultrasound imaging system designed to complement mammography by providing detailed images of breast tissue, enhancing cancer detection, especially in women with dense breasts.
Q2: How does SoftVue UST improve breast cancer screening?
The system increases the sensitivity and specificity of cancer detection in dense breast tissue, helping radiologists differentiate between benign and malignant masses more effectively.
Q3: What were the key findings of the study on SoftVue UST?
The study found a 25% improvement in sensitivity for detecting BI-RADS 4 or higher lesions and an 8% improvement in specificity for BI-RADS 3 lesions when SoftVue UST was used alongside mammography.
Q4: Who participated in the study?
The study involved 140 cases and 32 MQSA-qualified radiologists from diverse academic, private, and community-based practices.
Q5: When will the federal breast density notification mandate take effect?
The mandate for federal breast density notifications will take effect in September 2024.
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