Breast CancerNCT06878547
VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2025to 24 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Desma Jones, 984-974-8771, desma_jones@med.unc.edu
About this study
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.
Read the 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
- Being tested
- Ultrasound
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Non-invasive breast imaging using VisR ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Women with benign breast masses | Participants in this group will be imaged once prior to biopsy, as part of the first study arm Receives: 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 Receives: 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 Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to end of neoadjuvant systemic therapy, assessed up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start7 Mar 2025
- Primary completion25 Aug 2027 (estimated)
- Study completion24 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Caterina Gallippi, PhD, Principal investigator, Lampe Joint Department of Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878547
- Sponsor's protocol ID
- LCCC2449
- Other IDs
- 5R01CA281150-02
- Status last verified
- May 2026
- First submitted
- 3 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer Patients
- ClinicalTrials.gov ID
- NCT06878547
- Acronym / sponsor ID
- LCCC2449
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Ultrasound screening, Ultrasound elastography, ARFI Ultrasound, VisR Ultrasound, Breast cancer diagnosis, Malignant breast lesion, Benign breast lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 24 Feb 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with benign breast masses | – | Device: UltrasoundParticipants in this group will be imaged once prior to biopsy, as part of the first study arm |
| Women with malignant breast masses | – | Device: UltrasoundParticipants in this group will be imaged once prior to biopsy, as part of the first study arm |
| Women undergoing neoadjuvant systemic therapy (NAT) | – | Device: UltrasoundParticipants 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 |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundNon-invasive breast imaging using VisR ultrasound | Device | Women undergoing neoadjuvant systemic therapy (NAT), Women with benign breast masses, Women with malignant breast masses |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caterina Gallippi, PhD principal investigator
Lampe Joint Department of Biomedical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desma Jones (919-843-9463, desma_jones@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARFI Peak Displacement (PD) in lesion (Study Arm 1) (time frame: Baseline imaging). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.