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.

NCT Number	NCT06878547
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: National Cancer Institute (NCI)
Conditions	Breast Cancer
Enrollment	250 participants
Start Date	2025-03-07
Primary Completion	2027-08-25 (estimated)
Study Completion	2028-02-24 (estimated)
Updated on ClinicalTrials.gov	2026-06-02