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NCT Number: NCT06878547

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

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.

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Key information

Conditions

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

Age range

20 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location status: Recruiting

Location contact

Desma Jones

CONTACT

[email protected]

984-974-8771

About this study

The purpose of the proposed research is to evaluate in vivo the feasibility of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy for clinical diagnostic breast imaging. These biomarkers will be measured using novel, noninvasive ultrasound technologies under development in Dr. Gallippi's laboratory: 1) Acoustic Radiation Force Impulse (ARFI) ultrasound for interrogating tissue stiffness, 2) Viscoelastic Response (VisR) ultrasound for assessing tissue elasticity and viscosity, and 3) Dynamic Displacement Anisotropy Imaging (DDAI) for measuring tissue anisotropy. This proposed pilot study has two unblinded arms, corresponding to two aims from our NIH R01 grant.

The hypothesis of this study is that ultrasound-derived stiffness, elasticity, viscosity, and anisotropy measured in breast tissue will differ between patients with malignant and benign lesions, and between patients who are responsive versus non-responsive to neoadjuvant systemic therapy (NAT). To test these hypotheses, the research team will pursue the following specific aims from the R01 grant (specific aim #1 is being addressed by a different ongoing study, IRB #24-0122):

Aim #2: Correlate in vivo VisR outcomes to collagen fiber organization in malignant and benign breast masses and surrounding stroma in women, and demonstrate the clinical relevance of such to cancer diagnosis and staging. ARFI, VisR, and DDAI imaging will be performed on women with malignant or benign breast tumors to determine their diagnostic value in predicting malignancy. Results will be compared with histological assessment of collagen fiber organization.

Aim #3: Correlate in vivo VisR outcomes to pre- and post-NAT collagen fiber organization, and demonstrate the clinical relevance of such to predicting pathologic complete response (pCR) to NAT in women. ARFI, VisR, and DDAI imaging will be performed on women with malignant breast tumors undergoing neoadjuvant systemic therapy to monitor changes in mechanical properties during treatment and predict response to chemotherapy from early timepoints. Results will be compared with histological assessment of collagen fiber organization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Arm 1):

  • 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

(Arm 1):

  • 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

Treatment and study plan

Ultrasound

Device

Non-invasive breast imaging using VisR ultrasound

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caterina Gallippi, PhD

CONTACT

[email protected]

9198436647

Desma Jones

CONTACT

[email protected]

919-843-9463

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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