Status:
RECRUITING
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-90 years
Brief 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 chemother...
Detailed Description
The purpose of the proposed research is to evaluate in vivo the feasibility of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy for clinical diagnostic breast imaging. T...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 24 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06878547
Start Date
March 7 2025
End Date
February 24 2028
Last Update
May 28 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514