VisR for Noninvasively Interrogating Stromal Collagen Organization as a Breast Cancer Biomarker: Evaluation of Compression in Control Subjects
NCT Number: NCT06547034
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer
Interventions: DEVICE: Ultrasound
Sponsor: UNC Lineberger Comprehensive Cancer Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2025-03-01

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.

Primary Outcome Measures: ARFI PD at 0% Strain, Average ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation., Baseline imaging|ARFI PD at 10% Strain, Average ARFI Peak Displacement (PD) value across imaging angles with 10% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation., Baseline imaging|ARFI PD at 25% Strain, Average ARFI Peak Displacement (PD) value across imaging angles with 25% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation., Baseline imaging|VisR Tau at 0% Strain, Average VisR Tau value across imaging angles with 0% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR Tau at 10% Strain, Average VisR Tau value across imaging angles with 10% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR Tau at 25% Strain, Average VisR Tau value across imaging angles with 25% strain applied. Tau - relaxation constant of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RE at 0% Strain, Average VisR RE value across imaging angles with 0% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RE at 10% Strain, Average VisR RE value across imaging angles with 10% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RE at 25% Strain, Average VisR RE value across imaging angles with 25% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RV at 0% Strain, Average VisR RV value across imaging angles with 0% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RV at 10% Strain, Average VisR RV value across imaging angles with 10% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RV at 25% Strain, Average VisR RV value across imaging angles with 25% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|ARFI PD DoA at 0% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 0% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation., Baseline imaging|ARFI PD DoA at 10% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 10% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation., Baseline imaging|ARFI PD DoA at 25% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum ARFI Peak Displacement (PD) value across imaging angles with 25% strain applied. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation., Baseline imaging|VisR RE DoA at 0% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 0% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RE DoA at 10% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 10% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RE DoA at 25% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RE value across imaging angles with 25% strain applied. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging|VisR RV DoA at 0% Strain, Degree of anisotropy (DoA) defined as ratio of maximum to minimum VisR RV value across imaging angles with 0% strain applied. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence., Baseline imaging