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VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker: Evaluation of Compression in Control Subjects

NCT06547034 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-03-28

No results posted yet for this study

Summary

Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for elasticity, viscosity, and anisotropy. To this end, we will investigate the effect of applied compression during imaging on elasticity, viscosity, and anisotropy measurements.

Participants: Twenty women with negative mammograms and no history of breast disease will be recruited. The subjects will be split into two cohorts of ten each, the first cohort aged 30-45 and the second cohort aged 46-90. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals.

Procedures (methods): In this exploratory clinical study, the investigators will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound measurements of elasticity, viscosity, and anisotropy in healthy breast tissue vary based on applied pre-compression. This unblinded, open-label study will be conducted in 20 women with negative mammogram results and no history of breast disease.

Conditions

Interventions

DEVICE

Ultrasound

Breast Ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Caterina Gallippi, PhD · University of North Carolina, Chapel Hill

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547034 on ClinicalTrials.gov