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

NCT06547034 | Completed FDA Device

• 2 other identifiers: LCCC24115R01CA281150-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Screening

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

Ages 30-45

Women ages 30-45 who have received a mammogram in the past year with negative results and have no history of breast disease.

Device: Ultrasound

Ages 46-90

Women ages 46-90 who have received a mammogram in the past year with negative results and have no history of breast disease.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Breast Ultrasound

Ages 30-45; Ages 46-90

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two cohorts of patients with negative mammograms and no history of breast disease will be recruited. Both cohorts will have ten women each. The first cohort will be women ages 30-45, and the second cohort will be women ages 46-90.

You may qualify if:

• Patients are 30-90 years of age
• Patients have received a negative result from mammogram screening in past year
• Patients have no history of breast disease
• Informed consent obtained and signed

You may not qualify if:

• Inability to provide informed consent
• Inability to communicate in English
• Inability to remain motionless for 15 minutes
• Any pathologies of the breast or history of breast disease
• Patients who are pregnant
• Patients who are lactating
• Patients with breast implants
• Patients with implanted cardioverters or pacemakers

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Caterina Gallippi, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: October 16, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)