RecruitingNCT06878547

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

Enrollment

250 participants

Start Date

Mar 7, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of ultrasound — called VisR ultrasound — to non-invasively measure the stiffness and structure of fibrous tissue (collagen) in the breast. The goal is to find out whether this technique can detect changes linked to breast cancer without needing a needle or biopsy. **You may be eligible if:** - You are a woman between 20 and 90 years old - You have a breast lesion that is visible on regular ultrasound during a diagnostic workup - Your lesion has been rated as suspicious (BI-RADS 4a, 4b, 4c, or 5) - OR you are a healthy volunteer without known breast disease (for a comparison group) **You may NOT be eligible if:** - You are unable to provide consent - You have conditions that would make the ultrasound procedure unsafe - Your lesion is not visible on standard ultrasound Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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