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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: f
View:

• 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)

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Desma Jones
desma_jones@med.unc.edu
919-843-9463
Backup
Caterina Gallippi, PhD
cmgallip@email.unc.edu
9198436647
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2028-02-24
Participants
Target number of participants: 250
Treatments
Women with benign breast masses
Participants in this group will be imaged once prior to biopsy, as part of the first study arm
Women with malignant breast masses
Participants in this group will be imaged once prior to biopsy, as part of the first study arm
Women undergoing neoadjuvant systemic therapy (NAT)
Participants in this group will be imaged once before starting NAT, once approximately midway through NAT, and once after completion of NAT, as part of the second study arm
Related Therapeutic Areas
Sponsors
Leads: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov