# VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $592,393

## Abstract

PROJECT SUMMARY
Breast cancer is now the most prevalent cancer, with 2.3 million women diagnosed and 685,000 deaths
globally. Although, the death rate has declined by about 1% per year over the last decade due in large part to
earlier detection through screening, the current screening standard, digital mammography, lacks sensitivity and
is challenged in radiographically dense breasts. Sensitivity in dense breasts is improved by magnetic
resonance imaging (MRI), but required contrast enhancement and substantial additional cost are drawbacks. A
non-contrast, low-cost alternative, ultrasound strain elastography (SE) has been shown to achieve high
sensitivity and specificity for breast cancer diagnosis. However, while SE diagnoses suspicious breast massed
by interrogating tissue stiffness, the underlying cause of stiffening is not discerned. Among the many possible
causes, stromal collagen organization is newly a focus of intense interest due to its recently proven association
with breast cancer stage, prognosis, treatment response, and other clinical features. Therefore, delineating
stromal collagen organization in vivo would not only improve breast cancer diagnosis and treatment
management but also help to elucidate the complex and poorly understood pathophysiology of breast cancer
development, progression, and aggressiveness. One approach to noninvasively evaluating stromal collagen
organization in the breast is ultrasound shear wave elastography (SWE), but shear wave propagation is
inhibited in 63% of malignant breast masses, leading to low-quality measurements. The lack of a robust
ultrasound approach to interrogating stromal collagen organization represents a major gap in exploiting a
rapidly emerging and highly promising biomarker for breast cancer. To fill this gap, our group has developed
Viscoelastic Response (VisR) ultrasound, an on-axis approach to interrogating collagen fiber organization via
stiffness anisotropy in breast masses and surrounding stroma without observing shear wave propagation. Our
preliminary in vivo data, acquired in 30 women with BIRADS-4 or -5 masses, demonstrate that VisR-derived
ratio of mass-to-surrounding tissue stiffness anisotropy (RMSA) differentiated biopsy-confirmed malignant
(n=9) from benign (n=21) breast masses with a sensitivity of 95% and a specificity of 89%. Further, in our pilot
feasibility study of four women monitored serially while undergoing neoadjuvant chemotherapy (NAC), VisR
RMSA trended from malignant to benign indication with response to treatment. The success of our
investigations motivates further advancement of VisR RMSA measurement technology, its extension to
revealing the relationship between VisR RMSA outcomes and stromal collagen organization, and broader
application to cancer detection and treatment monitoring. We hypothesize: Advanced VisR RMSA correlates to
stromal collagen fiber organization, which is relevant to differentiating malignant from benign breast masses
and predicting p...

## Key facts

- **NIH application ID:** 10827486
- **Project number:** 5R01CA281150-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Caterina M Gallippi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $592,393
- **Award type:** 5
- **Project period:** 2023-04-15 → 2027-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10827486

## Citation

> US National Institutes of Health, RePORTER application 10827486, VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker (5R01CA281150-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10827486. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*