VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
Purpose: This study will evaluate how measurements of tissue stiffness, viscosity, and anisotropy using non-invasive ultrasound imaging correlate with breast tumor malignancy and response to chemotherapy. Participants: Up to 200 women with benign or malignant breast tumors for arm 1 and up to 50 women undergoing neoadjuvant chemotherapy in the breast for arm 2 will be recruited. Procedures (methods): The research team will use an ultrasound scanner to acquire non-invasive elastography data from the breast of each subject, testing a range of transducer rotation angles. Transducer position will be monitored using a position sensor during imaging.
• Subjects are 20-90 years of age
• Subjects are female
• Breast lesion is sonographically visible with B-Mode ultrasound on diagnostic workup
• Breast lesion(s) have BI-RADS 4a, 4b, 4c, or 5 rating
• Subjects are 20-90 years of age
• Subjects are female
• Breast lesion is sonographically visible with B-Mode ultrasound on diagnostic workup
• Breast lesion(s) have BI-RADS 6 rating, subject will be undergoing NAT for stage 2 or 3 malignant breast lesion(s)