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RECRUITING
NCT06878547

VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2025-03-07

Completion Date

2028-02-24

Last Updated

2025-05-28

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Ultrasound

Non-invasive breast imaging using VisR ultrasound

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States