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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06878547
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound — DEVICE
    Non-invasive breast imaging using VisR ultrasound

Study Details

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.

Key Dates

Start date
Mar 7, 2025
Status verified
May 2026
Primary completion
Aug 25, 2027
Completion
Feb 24, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Women with benign breast masses
    Participants in this group will be imaged once prior to biopsy, as part of the first study arm
  • Arm: Women with malignant breast masses
    Participants in this group will be imaged once prior to biopsy, as part of the first study arm
  • 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

Primary Outcome Measure

ARFI Peak Displacement (PD) in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Desma Jones
[email protected]
984-974-8771

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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