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

NCT06878547 | Recruiting FDA Device

• 2 other identifiers: LCCC24495R01CA281150-02
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Ultrasound screening; Ultrasound elastography; ARFI Ultrasound; VisR Ultrasound; Breast cancer diagnosis; Malignant breast lesion; Benign breast lesion; Neoadjuvant chemotherapy; Non-invasive imaging; Tissue anisotropy; Elasticity; Viscosity

Outcome Measures

Primary Outcomes (24)

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

  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.

  Baseline imaging

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

  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.

  Baseline imaging

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

  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.

  Baseline imaging

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

  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.

  Baseline imaging

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

  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.

  Baseline imaging

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

  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.

  Baseline imaging

• ARFI PD DoA in lesion (Study Arm 1)

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

  Baseline imaging

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

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

  Baseline imaging

• VisR RE DoA in lesion (Study Arm 1)

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

  Baseline imaging

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

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

  Baseline imaging

• VisR RV DoA in lesion (Study Arm 1)

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

  Baseline imaging

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

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

  Baseline imaging

• ARFI Peak Displacement (PD) in lesion (Study Arm 2)

  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.

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 2)

  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.

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR Relative Elasticity (RE) in lesion (Study Arm 2)

  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.

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 2)

  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.

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR Relative Viscosity (RV) in lesion (Study Arm 2)

  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.

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 2)

  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.

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• ARFI PD DoA in lesion (Study Arm 2)

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

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• ARFI PD DoA in surrounding tissue (Study Arm 2)

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

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR RE DoA in lesion (Study Arm 2)

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

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR RE DoA in surrounding tissue (Study Arm 2)

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

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR RV DoA in lesion (Study Arm 2)

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

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

• VisR RV DoA in surrounding tissue (Study Arm 2)

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

  From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months

Study Arms (3)

Women with benign breast masses

Participants in this group will be imaged once prior to biopsy, as part of the first study arm

Device: Ultrasound

Women with malignant breast masses

Participants in this group will be imaged once prior to biopsy, as part of the first study arm

Device: Ultrasound

Women undergoing neoadjuvant systemic therapy (NAT)

Participants in this group will be imaged once before starting NAT, once approximately midway through NAT, and once after completion of NAT, as part of the second study arm

Device: Ultrasound

Interventions

Ultrasound DEVICE

Non-invasive breast imaging using VisR ultrasound

Women undergoing neoadjuvant systemic therapy (NAT); Women with benign breast masses; Women with malignant breast masses

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be patients 20-90 years of age. In the first study arm, patients with suspicious breast lesions that are rated 4 (suspicious)or 5 (highly suggestive of malignancy) on the BI-RADS scale will be recruited. In the second study arm, patients with confirmed malignant breast lesion (s) (BI-RADS 6) who are to undergo neoadjuvant systemic therapy will be recruited. All patients will be recruited from and imaged at the University of North Carolina Hospitals. Based on local demographics, we estimate that roughly 20% will be racial and ethnic minorities. Children will not be included in this study. There will be no randomization to study arms and no intervention beyond ARFI, VisR, and DDAI ultrasound imaging.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• Inability to provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy and resection samples will be retained for histopathology

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

  Lampe Joint Department of Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desma Jones

CONTACT

919-843-9463; desma_jones@med.unc.edu

Caterina Gallippi, PhD

CONTACT

9198436647; cmgallip@email.unc.edu

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 17, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): February 24, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-04

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)