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

NCT ID: NCT06878547

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2028-02-24

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Women with benign breast masses

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

Ultrasound

Intervention Type: DEVICE

Non-invasive breast imaging using VisR ultrasound

Women with malignant breast masses

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

Ultrasound

Intervention Type: DEVICE

Non-invasive breast imaging using VisR 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

Ultrasound

Intervention Type: DEVICE

Non-invasive breast imaging using VisR ultrasound

Interventions

Ultrasound

Non-invasive breast imaging using VisR ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caterina Gallippi, PhD

Role: PRINCIPAL_INVESTIGATOR

Lampe Joint Department of Biomedical Engineering

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Desma Jones

Role: CONTACT

desma_jones@med.unc.edu

919-843-9463

Caterina Gallippi, PhD

Role: CONTACT

cmgallip@email.unc.edu

9198436647

Facility Contacts

Desma Jones

Role: primary

desma_jones@med.unc.edu

984-974-8771

Other Identifiers

5R01CA281150-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC2449

Identifier Type: -

Identifier Source: org_study_id