Recruiting

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

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…

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ClinicalTrials.gov IDNCT06878547

PhaseNot Applicable

Enrollment250

SponsorUNC Lineberger Comprehensive Cancer Center

Age20 Years – 90 Years

SexFEMALE

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Conditions studied

Breast Cancer

About this study

Interventions

Device: Ultrasound — Non-invasive breast imaging using VisR ultrasound

Primary outcomes

ARFI Peak Displacement (PD) in lesion (Study Arm 1) (Baseline imaging)
ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 1) (Baseline imaging)
VisR Relative Elasticity (RE) in lesion (Study Arm 1) (Baseline imaging)
VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 1) (Baseline imaging)
VisR Relative Viscosity (RV) in lesion (Study Arm 1) (Baseline imaging)
VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1) (Baseline imaging)
ARFI PD DoA in lesion (Study Arm 1) (Baseline imaging)
ARFI PD DoA in surrounding tissue (Study Arm 1) (Baseline imaging)

Eligibility information

Inclusion Criteria (Arm 1): * 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 Exclusion Criteria (Arm 1): * 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 * Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest * Subject is male Inclusion Criteria (Arm 2): * 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) Exclusion Criteria (Arm 2): * 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 * Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest * Subject is male

Study locations

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27514 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.