Actively Recruiting
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-05-28
250
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 20 to 90 years
- Breast lesion visible on B-Mode ultrasound during diagnostic workup
- For Arm 1: Breast lesion has BI-RADS rating of 4a, 4b, 4c, or 5
- For Arm 2: Breast lesion has BI-RADS 6 rating and planned neoadjuvant therapy for stage 2 or 3 malignant breast tumor
You will not qualify if you...
- Unable to provide informed consent
- Unable to communicate in English
- Unable to remain still for 15 minutes during imaging
- Presence of breast implants
- Breast mass deeper than 4 cm from skin surface
- Pregnant or lactating
- Presence of pacemaker or implanted cardioverter
- History of mastectomy
- Previous biopsy, surgery, or excision at the mass site
- Male gender
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
D
Desma Jones
CONTACT
C
Caterina Gallippi, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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