Back to search results

VisR Ultrasound for Breast Cancer Biomarker Evaluation

This study is looking at a new way to use ultrasound, called VisR ultrasound, to learn more about breast cancer. Researchers want to see if measurements of tissue stiffness, elasticity, and other properties using this special ultrasound can help tell the difference between cancerous and non-cancerous breast lumps. They also want to see if these measurements can show how well chemotherapy is working. You might be able to join if you are a woman between 20 and 90 years old with a breast lesion (lump) that can be seen on a regular ultrasound and has a BI-RADS rating of 4a, 4b, 4c, or 5. The study will measure things like ARFI Peak Displacement and VisR Relative Elasticity in your breast lesion and the tissue around it during a single imaging session.

Study design
This is an observational study involving up to 250 women. It has two unblinded arms, meaning both you and the researchers will know what is being studied.
What's involved
You would undergo non-invasive breast imaging using a special ultrasound scanner. This involves remaining still for about 15 minutes during the imaging session.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06878547

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

Recruiting
Not specifiedAges 20–90Observational
UNC Lineberger Comprehensive Cancer Center
~250 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ARFI Peak Displacement (PD) in lesion (Study Arm 1)
Measured over Baseline imaging
+23 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaBreast Lesion

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Caterina Gallippi, PhD · PRINCIPAL_INVESTIGATOR · Lampe Joint Department of Biomedical Engineering

Who to contact

Desma Jones
[email protected]
919-843-9463
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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)

Exclusion

Inability to provide informed consent
Inability to communicate in English
Inability to remain motionless for 15 minutes
Subjects with breast implants
Breast mass is deeper than 4 cm from skin surface
Subjects who are pregnant or lactating
Subjects who have pacemakers or implanted cardioverters
Subjects with a history of mastectomy
Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest
Subject is male
Inability to provide informed consent
Inability to communicate in English
Inability to remain motionless for 15 minutes
Subjects with breast implants
Breast mass is deeper than 4 cm from skin surface
Subjects who are pregnant or lactating
Subjects who have pacemakers or implanted cardioverters
Subjects with a history of mastectomy
Previous biopsy or surgery to the site of the mass, surgical excision of mass of interest
Subject is male

What this trial measures

  • ARFI Peak Displacement (PD) in lesion (Study Arm 1)Baseline imaging

    Average ARFI Peak Displacement (PD) value inside of lesion. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.

  • ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 1)Baseline imaging

    Average ARFI Peak Displacement (PD) value in an area of breast tissue outside of lesion. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.

  • VisR Relative Elasticity (RE) in lesion (Study Arm 1)Baseline imaging

    Average VisR RE value in lesion. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 1)Baseline imaging

    Average VisR RE value in area of tissue outside of the lesion. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • VisR Relative Viscosity (RV) in lesion (Study Arm 1)Baseline imaging

    Average VisR RV value in lesion. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1)Baseline imaging

    Average VisR RV value in area of tissue outside of the lesion. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • ARFI PD DoA in lesion (Study Arm 1)Baseline imaging

    Ratio of maximum to minimum (DoA) of ARFI PD inside the lesion over four imaging angles

  • ARFI PD DoA in surrounding tissue (Study Arm 1)Baseline imaging

    Ratio of maximum to minimum (DoA) of ARFI PD in an area of tissue outside of the lesion over four imaging angles

  • VisR RE DoA in lesion (Study Arm 1)Baseline imaging

    Ratio of maximum to minimum (DoA) of VisR RE inside the lesion over four imaging angles

  • VisR RE DoA in surrounding tissue (Study Arm 1)Baseline imaging

    Ratio of maximum to minimum (DoA) of VisR RE in an area of tissue outside of the lesion over four imaging angles

  • VisR RV DoA in lesion (Study Arm 1)Baseline imaging

    Ratio of maximum to minimum (DoA) of VisR RV inside the lesion over four imaging angles

  • VisR RV DoA in surrounding tissue (Study Arm 1)Baseline imaging

    Ratio of maximum to minimum (DoA) of VisR RV in an area of tissue outside of the lesion over four imaging angles

  • ARFI Peak Displacement (PD) in lesion (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Average ARFI Peak Displacement (PD) value inside of lesion. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.

  • ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Average ARFI Peak Displacement (PD) value in an area of breast tissue outside of lesion. Peak Displacement (PD) - Maximum displacement of tissue in the breast after an Acoustic Radiation Force Impulse (ARFI) excitation.

  • VisR Relative Elasticity (RE) in lesion (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Average VisR RE value in lesion. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Average VisR RE value in area of tissue outside of the lesion. RE - relative elasticity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • VisR Relative Viscosity (RV) in lesion (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Average VisR RV value in lesion. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Average VisR RV value in area of tissue outside of the lesion. RV - relative viscosity (relative to force applied) of breast tissue measured using a Viscoelastic Response (VisR) ultrasound imaging sequence.

  • ARFI PD DoA in lesion (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Ratio of maximum to minimum (DoA) of ARFI PD inside the lesion over four imaging angles

  • ARFI PD DoA in surrounding tissue (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Ratio of maximum to minimum (DoA) of ARFI PD in an area of tissue outside of the lesion over four imaging angles

  • VisR RE DoA in lesion (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Ratio of maximum to minimum (DoA) of VisR RE inside the lesion over four imaging angles

  • VisR RE DoA in surrounding tissue (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Ratio of maximum to minimum (DoA) of VisR RE in an area of tissue outside of the lesion over four imaging angles

  • VisR RV DoA in lesion (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Ratio of maximum to minimum (DoA) of VisR RV inside the lesion over four imaging angles

  • VisR RV DoA in surrounding tissue (Study Arm 2)From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

    Ratio of maximum to minimum (DoA) of VisR RV in an area of tissue outside of the lesion over four imaging angles