VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
Eligible age
20–90 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: UNC Lineberger Comprehensive Cancer Center
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ Inability to provide informed consent
- ✕ Inability to communicate in English
- ✕ Inability to remain motionless for 15 minutes
- ✕ Subjects with breast implants
- ✕ Breast mass is deeper than 4 cm from skin surface
- ✕ Subjects who are pregnant or lactating
- ✕ Subjects who have pacemakers or implanted cardioverters
- ✕ Subjects with a history of mastectomy
Where it's recruiting
Chapel Hill
Source: ClinicalTrials.gov · NCT06878547 · last updated 2026-06-02