Recruiting

VisR Ultrasound

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06878547

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound

Study Details

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

Study ID

NCT06878547

Start date

Mar 7, 2025

Status verified date

May, 2026

Completion date

Feb 24, 2028

Anticipated

Primary completion date

Aug 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Women with benign breast masses

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

Women with malignant breast masses

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

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

Interventions

Ultrasound

Non-invasive breast imaging using VisR ultrasound

Primary outcome measure

  • ARFI Peak Displacement (PD) in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]
  • ARFI Peak Displacement (PD) in surrounding tissue (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR Relative Elasticity (RE) in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR Relative Elasticity (RE) in surrounding tissue (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR Relative Viscosity (RV) in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR Relative Viscosity (RV) in surrounding tissue (Study Arm 1) [ Time Frame: Baseline imaging ]
  • ARFI PD DoA in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]
  • ARFI PD DoA in surrounding tissue (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR RE DoA in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR RE DoA in surrounding tissue (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR RV DoA in lesion (Study Arm 1) [ Time Frame: Baseline imaging ]
  • VisR RV DoA in surrounding tissue (Study Arm 1) [ Time Frame: Baseline imaging ]
  • ARFI Peak Displacement (PD) in lesion (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • 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 ]
  • VisR Relative Elasticity (RE) in lesion (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • 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 ]
  • VisR Relative Viscosity (RV) in lesion (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • 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 ]
  • ARFI PD DoA in lesion (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • ARFI PD DoA in surrounding tissue (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • VisR RE DoA in lesion (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • VisR RE DoA in surrounding tissue (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • VisR RV DoA in lesion (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]
  • VisR RV DoA in surrounding tissue (Study Arm 2) [ Time Frame: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months ]

Central Contacts and Locations

Central contacts

Desma Jones

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

Caterina Gallippi, PhD

9198436647cmgallip@email.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Desma Jones

984-974-8771desma_jones@med.unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-06-02.