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NCT06878547 · UNC Lineberger Comprehensive Cancer Center

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

What this study is about

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.

View original scientific description

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.

Interventions

DEVICE

Ultrasound

Non-invasive breast imaging using VisR ultrasound

Primary outcome measures

ARFI Peak Displacement (PD) in lesion (Study Arm 1)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 Inclusion Criteria (Arm 2):
  • 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 Criteria (Arm 2):
  • 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

Where

  • Chapel Hill, North Carolina

Collaborators

National Cancer Institute (NCI)

Related conditions & keywords

Breast CancerUltrasound screeningUltrasound elastographyARFI UltrasoundVisR UltrasoundBreast cancer diagnosisMalignant breast lesionBenign breast lesionNeoadjuvant chemotherapyNon-invasive imagingTissue anisotropyElasticityViscosity

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations

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Study locations

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RECRUITING

Chapel Hill

North Carolina

Location available
View Chapel Hill location page

Express your interest

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Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Breast Cancer Treatment in Chapel Hill?

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Breast Cancer Treatment Options in Chapel Hill, North Carolina

If you're searching for Breast Cancer treatment in Chapel Hill, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chapel Hill and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Breast Cancer. All study-related care is provided at no cost to participants.

Local Sites
1 locations in North Carolina
Now Enrolling
Up to 250 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Breast Cancer?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Breast Cancer

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Breast Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06878547. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.