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ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer

ARFI, VisR and DDAI Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03785782
Enrollment
45
Registered
2018-12-24
Start date
2018-05-10
Completion date
2021-07-15
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Screening

Brief summary

Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. Participants: Forty women with breast lesions that have a BIRADS-4 or BIRADS-5 rating and forty women undergoing neoadjuvant chemotherapy (NAC) for malignant breast lesions will be recruited. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals. Procedures (methods): In this exploratory clinical study, the investigators will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound reliably detect malignant breast masses (Aim #1) and distinguish masses that respond to chemotherapy from those that do not (Aim #2). The ARFI, VisR, and DDAI imaging location will be on the surface of the breast, above the suspicious or malignant mass. This unblinded, open-label, exploratory study will be conducted in 40 women with diagnosed BIRADS-4 or -5 masses in Aim #1 and in 40 women with malignant masses undergoing neoadjuvant chemotherapy (NAC) in Aim #2.

Detailed description

The primary objective of breast cancer screening is to identify early stage cancer, or precancerous lesions, at a time before symptoms emerge and when treatment is likely to result in a cure. Screening is beneficial when it averts progression of disease to metastasis and/or death, but adverse effects to patients (and unnecessary medical expense) may result downstream from false positives and indiscrimination of masses that will not respond to treatment. The sensitivity of digital mammography, the current screening standard in the US, has been reported in the range of 0.40 to 0.85, with a positive predictive value of 0.31. Sensitivity is increased by augmenting mammography with MRI and B-Mode ultrasound, but false positive rates may also increase3. There exists a vital need for a screening technology that exhibits high sensitivity and specificity for cancer detection with early identification of unresponsive masses. This urgent need could be met by exploiting new imaging biomarkers. Specifically, the mechanical properties of breast tissue have been used for cancer detection, with both elasticity and viscosity demonstrated for discriminating malignant from benign lesions. Further, tissue anisotropy has been shown to correlate with core biopsy result and tumor grade, with large cancers significantly more anisotropic than small cancers. Importantly, while both MRI and ultrasound can be used to measure these biomarkers, ultrasound's cost effectiveness and ease of implementation render it an efficient platform to pursue. The long-term goal of this research program is to develop a new ultrasound-based breast-screening tool to augment mammography. As a critical first step toward achieving this goal, the primary objective of the proposed research is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy. 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. These technologies have been demonstrated previously for delineating atherosclerosis, muscular dystrophy, and renal dysfunction. A.1.2.State the research question(s) (i.e., specific study aims and/or hypotheses). The investigators hypothesize that ultrasound-derived stiffness, elasticity, viscosity, and anisotropy will correlate with lesion malignancy and response to treatment. To test this hypothesis, they will pursue the following specific aims: Aim #1: Quantify the ability of ultrasound-derived stiffness, elasticity, viscosity, and anisotropy to detect malignancy. ARFI, VisR, and DDAI imaging will be performed on suspicious breast lesions in 40 women with BIRADS-4a, 4b, 4c, or -5 ratings. The diagnostic accuracy of imaging metrics will analyzed, with malignancy confirmed by histology as the outcome. Aim #2: Quantify the ability of ultrasound-derived stiffness, elasticity, viscosity, and anisotropy to predict a positive response to treatment. ARFI, VisR, and DDAI imaging will be performed serially - once every four weeks over the course of neoadjuvant chemotherapy (NAC) - on malignant breast lesions in 40 women. Changes in outcome metrics over time will be correlated to overall reduction in tumor size (diameter and area). The ability of ultrasound metrics to predict a positive response to treatment will be examined. A positive response to treatment will be determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

Interventions

DEVICEUltrasound

Breast ultrasound

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

\- Aim 1: Inclusion Criteria: * Patients are 30-90 years of age * Patients have breast masses with BIRADS 4a, 4b, 4c, or 5 rating * Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Informed consent obtained and signed Aim 2: Inclusion Criteria: * Patients are 30-90 years * Patients who are or will be undergoing neoadjuvant chemotherapy (NAC) for stage 2 or 3 malignant breast lesions * Lesion is sonographically visible with B-Mode ultrasound on diagnostic workup * Informed consent is obtained and signed

Exclusion criteria

Subjects who meet any of the

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Peak Displacement (PD) for Detecting MalignancyBaseline imagingThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate peak displacement (PD) and correlated with biopsy findings of malignant or benign. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an Acoustic Radiation Force Impulse (ARFI) excitation. Participants who have undergone breast ultrasonogram were categorized as BIRADS-4a, 4b, 4c, or -5 masses.
Weighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.Up to 8 monthsThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate peak displacement (PD) and correlated with biopsy findings of malignant or benign. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an Acoustic Radiation Force Impulse (ARFI) excitation.
Weighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant ChemotherapyUp to 8 monthsThe ultrasound data was processed to calculate displacement at a given time (TD) for ARFI and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a sacoustic pulse is transmitted into tissue, causing it to displace and recover in \<1 ms. The tissue displacement was used to estimate stiffness and viscosity. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesion not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.
Weighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.Up to 8 monthsThe ultrasound data will be processed to calculate relative elasticity (RE) and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesion not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.
Weighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.Up to 8 monthsThe ultrasound data will be processed to calculate relative viscosity (RV) and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.
Weighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.Up to 8 monthsThe ultrasound data will be processed to calculate tissue mass (TM) for VisR and statistically correlated to the response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Tissue Mass (TM) - Qualitative estimate for tissue mass in the breast lesion based on VisR imaging. Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.
Comparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Up to 8 monthsThe ultrasound data will be processed to calculate the ratio of ARFI PD values at 90o versus 0 o transducer orientations for DDAI and statistically correlated to the response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover in less than a millisecond. The tissue displacement can be tracked and used to estimate stiffness and viscosity. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an ARFI excitation. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks btwn.
Comparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Up to 60 daysThe ultrasound data was processed to calculate ratio of VisR RE values at 90o versus 0o transducer orientations for DDAI and statistically correlated to response of treatment with neoadjuvant chemotherapy. Values were weighted based on the number of imaging visits during subjects' treatment. Participants were imaged at baseline and end of each chemo cycle. Patients were imaged 3-8 times w/ 3-4 weeks btwn scans. Viscoelastic Response (VisR) - Ultrasound technique in which an acoustic pulse is transmitted into the tissue, causing it to displace and recover. Tissue recovery is fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more over the course of chemotherapy.
Weighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Up to 8 monthsThe ultrasound data will be processed to calculate ratio of RV values at 90o versus 0o transducer orientations for DDAI and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesion not shrinking by 25% or more over the course of chemotherapy.
Correlation of Displacement at a Given Time (TD) for Detecting Malignancy.BaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate displacement at a given time (TD) for ARFI and correlated with biopsy findings of malignant or benign. Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into tissue, causing it to displace and recover in less than a millisecond. The tissue displacement can be tracked and used to estimate stiffness and viscosity. Participants were imaged at baseline.
Correlation of Relative Elasticity (RE) for Detecting Malignancy.BaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate relative elasticity (RE) and correlated with biopsy finding of malignant or benign. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging.
Correlation of Relative Viscosity (RV) for Detecting Malignancy.BaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate relative viscosity (RV) and correlated with biopsy findings of malignant or benign. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type
Correlation of Tissue Mass (TM) for VisR for Detecting MalignancyBaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate tissue mass (TM) for VisRand correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity.
Correlation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.BaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate ratio of ARFI PD values at 90o versus 0o transducer orientations for DDAI and correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover in less than a millisecond. The tissue displacement can be tracked and used to estimate stiffness and viscosity. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an ARFI excitation.
Correlation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.BaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate the ratio of VisR RE values at 90o versus 0o transducer orientations for DDAI and correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging.
Correlation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.BaselineThe correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate ratio of VisR RV values at 90o versus 0o transducer orientations for DDAI and correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Displacement at Time (TD) - Displacement of tissue in the breast lesion at time t=0.2 ms after an ARFI excitation. Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging.

Countries

United States

Participant flow

Participants by arm

ArmCount
Women Scheduled for Biopsy
Participants who have undergone breast ultrasonogram, categorized BIRADS-4a, 4b, 4c, or -5 masses requiring biopsy for the disease diagnosis.
39
Women Scheduled for Neoadjuvant Chemo
Participants who have undergone breast ultrasonogram, malignant breast tumor was confirmed with biopsy and scheduled to receive neoadjuvant chemotherapy.
5
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyinsufficient image quality.30
Overall Studytheir lesions' were not suitable for the study criteria20
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicWomen Scheduled for BiopsyTotalWomen Scheduled for Neoadjuvant Chemo
Age, Continuous53.0 years
STANDARD_DEVIATION 14
53.2 years
STANDARD_DEVIATION 14
54.4 years
STANDARD_DEVIATION 15.7
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants43 Participants4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
9 Participants10 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
28 Participants31 Participants3 Participants
Region of Enrollment
United States
39 participants44 participants5 participants
Sex: Female, Male
Female
39 Participants44 Participants5 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 5
other
Total, other adverse events
0 / 390 / 5
serious
Total, serious adverse events
0 / 390 / 5

Outcome results

Primary

Comparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.

The ultrasound data will be processed to calculate the ratio of ARFI PD values at 90o versus 0 o transducer orientations for DDAI and statistically correlated to the response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover in less than a millisecond. The tissue displacement can be tracked and used to estimate stiffness and viscosity. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an ARFI excitation. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks btwn.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo3.56 unitless ratioStandard Error 3.08
Biopsy Finding of MalignantComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo2.52 unitless ratioStandard Error 1.13
Biopsy Finding of BenignComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo2.11 unitless ratioStandard Error 1.29
Biopsy Finding of BenignComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo2.11 unitless ratioStandard Error 1.29
ARFI PD After Neoadjuvant Chemo 90 DegreesComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo7.99 unitless ratioStandard Error 5.8
ARFI PD After Neoadjuvant Chemo 90 DegreesComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo7.99 unitless ratioStandard Error 5.8
ARFI PD After Neoadjuvant Chemo 0 DegreeComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo6.06 unitless ratioStandard Error 4.27
ARFI PD After Neoadjuvant Chemo 0 DegreeComparison of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo2.68 unitless ratioStandard Error 0.1
p-value: 0.78Regression, Linear
Primary

Comparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.

The ultrasound data was processed to calculate ratio of VisR RE values at 90o versus 0o transducer orientations for DDAI and statistically correlated to response of treatment with neoadjuvant chemotherapy. Values were weighted based on the number of imaging visits during subjects' treatment. Participants were imaged at baseline and end of each chemo cycle. Patients were imaged 3-8 times w/ 3-4 weeks btwn scans. Viscoelastic Response (VisR) - Ultrasound technique in which an acoustic pulse is transmitted into the tissue, causing it to displace and recover. Tissue recovery is fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more over the course of chemotherapy.

Time frame: Up to 60 days

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo155.59 unitless ratioStandard Error 164.03
Biopsy Finding of MalignantComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo179.02 unitless ratioStandard Error 1.84
Biopsy Finding of BenignComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo185.64 unitless ratioStandard Error 83.47
Biopsy Finding of BenignComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo170.15 unitless ratioStandard Error 8.74
ARFI PD After Neoadjuvant Chemo 90 DegreesComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo69.45 unitless ratioStandard Error 33.08
ARFI PD After Neoadjuvant Chemo 90 DegreesComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo172.82 unitless ratioStandard Error 153.11
ARFI PD After Neoadjuvant Chemo 0 DegreeComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo107.00 unitless ratioStandard Error 81.34
ARFI PD After Neoadjuvant Chemo 0 DegreeComparison of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo160.95 unitless ratioStandard Error 16.97
p-value: 0.45Regression, Linear
Primary

Correlation of Displacement at a Given Time (TD) for Detecting Malignancy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate displacement at a given time (TD) for ARFI and correlated with biopsy findings of malignant or benign. Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into tissue, causing it to displace and recover in less than a millisecond. The tissue displacement can be tracked and used to estimate stiffness and viscosity. Participants were imaged at baseline.

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Displacement at a Given Time (TD) for Detecting Malignancy.4.16 micronsStandard Error 2.76
Biopsy Finding of BenignCorrelation of Displacement at a Given Time (TD) for Detecting Malignancy.7.15 micronsStandard Error 5.54
p-value: 0.7465Regression, Logistic
Primary

Correlation of Peak Displacement (PD) for Detecting Malignancy

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate peak displacement (PD) and correlated with biopsy findings of malignant or benign. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an Acoustic Radiation Force Impulse (ARFI) excitation. Participants who have undergone breast ultrasonogram were categorized as BIRADS-4a, 4b, 4c, or -5 masses.

Time frame: Baseline imaging

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Peak Displacement (PD) for Detecting Malignancy4.5803 micronsStandard Error 2.9947
Biopsy Finding of BenignCorrelation of Peak Displacement (PD) for Detecting Malignancy8.628 micronsStandard Error 7.8776
p-value: 0.2988Regression, Logistic
Primary

Correlation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate ratio of ARFI PD values at 90o versus 0o transducer orientations for DDAI and correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover in less than a millisecond. The tissue displacement can be tracked and used to estimate stiffness and viscosity. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an ARFI excitation.

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of malignant4.88 unitless ratioStandard Error 3.4
Biopsy Finding of MalignantCorrelation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of benign9.84 unitless ratioStandard Error 8.31
Biopsy Finding of BenignCorrelation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of malignant4.30 unitless ratioStandard Error 2.45
Biopsy Finding of BenignCorrelation of Ratio of ARFI PD Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of benign8.10 unitless ratioStandard Error 7.34
p-value: 0.7447Regression, Logistic
Primary

Correlation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate the ratio of VisR RE values at 90o versus 0o transducer orientations for DDAI and correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging.

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of malignant139.66 unitless ratioStandard Error 100.61
Biopsy Finding of MalignantCorrelation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of benign77.47 unitless ratioStandard Error 62.73
Biopsy Finding of BenignCorrelation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of malignant117.26 unitless ratioStandard Error 70.72
Biopsy Finding of BenignCorrelation of Ratio of VisR RE Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of benign84.06 unitless ratioStandard Error 74.92
p-value: 0.0739Regression, Logistic
Primary

Correlation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate ratio of VisR RV values at 90o versus 0o transducer orientations for DDAI and correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Displacement at Time (TD) - Displacement of tissue in the breast lesion at time t=0.2 ms after an ARFI excitation. Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging.

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of malignant161.10 unitless ratioStandard Error 149.28
Biopsy Finding of MalignantCorrelation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of benign113.67 unitless ratioStandard Error 84.38
Biopsy Finding of BenignCorrelation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of malignant205.46 unitless ratioStandard Error 132.67
Biopsy Finding of BenignCorrelation of Ratio of VisR RV Values at 90o Versus 0o Transducer Orientations for Detecting Malignancy.Biopsy finding of benign157.49 unitless ratioStandard Error 142.23
p-value: 0.9995Regression, Logistic
Primary

Correlation of Relative Elasticity (RE) for Detecting Malignancy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate relative elasticity (RE) and correlated with biopsy finding of malignant or benign. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging.

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Relative Elasticity (RE) for Detecting Malignancy.125.59 1/millimeterStandard Error 69.69
Biopsy Finding of BenignCorrelation of Relative Elasticity (RE) for Detecting Malignancy.89.88 1/millimeterStandard Error 76.04
p-value: 0.0466Regression, Logistic
Primary

Correlation of Relative Viscosity (RV) for Detecting Malignancy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate relative viscosity (RV) and correlated with biopsy findings of malignant or benign. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Relative Viscosity (RV) for Detecting Malignancy.194.43 s/mStandard Error 170.13
Biopsy Finding of BenignCorrelation of Relative Viscosity (RV) for Detecting Malignancy.137.60 s/mStandard Error 116.95
p-value: 0.1567Regression, Logistic
Primary

Correlation of Tissue Mass (TM) for VisR for Detecting Malignancy

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate tissue mass (TM) for VisRand correlated with biopsy findings of malignant or benign. Participants were imaged according to their neoadjuvant chemotherapy schedule, at baseline and end of each chemotherapy type Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity.

Time frame: Baseline

Population: In total 34 subjects were included in the analysis. Six subjects were excluded because their lessons were unsuitable for the study criteria, had insufficient image quality, or were withdrawn. Biopsy finding of malignant:12 participants, Biopsy finding of benign: 22 participants. Women scheduled for neoadjuvant chemo are not included since they already have a malignant disease diagnosis.

ArmMeasureValue (MEAN)Dispersion
Biopsy Finding of MalignantCorrelation of Tissue Mass (TM) for VisR for Detecting Malignancy0.46 Kg/mStandard Error 0.5
Biopsy Finding of BenignCorrelation of Tissue Mass (TM) for VisR for Detecting Malignancy0.34 Kg/mStandard Error 0.31
p-value: 0.1837Regression, Logistic
Primary

Weighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant Chemotherapy

The ultrasound data was processed to calculate displacement at a given time (TD) for ARFI and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Acoustic Radiation Force Impulse (ARFI) - Ultrasound imaging technique in which a sacoustic pulse is transmitted into tissue, causing it to displace and recover in \<1 ms. The tissue displacement was used to estimate stiffness and viscosity. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesion not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantWeighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant ChemotherapyResponder to chemo2.3495 micronsStandard Error 1.3904
Biopsy Finding of MalignantWeighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant ChemotherapyNon-responders to chemo2.2757 micronsStandard Error 1.1146
Biopsy Finding of BenignWeighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant ChemotherapyResponder to chemo6.1222 micronsStandard Error 3.0388
Biopsy Finding of BenignWeighted Correlation Between Displacement at a Given Time (TD) for ARFI to Predict Response to Neoadjuvant ChemotherapyNon-responders to chemo3.0156 micronsStandard Error 1.2928
p-value: 0.43Regression, Linear
Primary

Weighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.

The correlation of each ultrasound metric will be analyzed by constructing separate receiver operating characteristic (ROC) curves. The ultrasound data were processed to calculate peak displacement (PD) and correlated with biopsy findings of malignant or benign. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans. Peak Displacement (PD) - Maximum displacement of tissue in the breast lesion after an Acoustic Radiation Force Impulse (ARFI) excitation.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantWeighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo2.4715 micronsStandard Error 1.4746
Biopsy Finding of MalignantWeighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo2.5268 micronsStandard Error 1.3869
Biopsy Finding of BenignWeighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo6.7281 micronsStandard Error 3.5461
Biopsy Finding of BenignWeighted Correlation Between Peak Displacement (PD) to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo3.2511 micronsStandard Error 1.3869
p-value: 0.36Regression, Linear
Primary

Weighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.

The ultrasound data will be processed to calculate ratio of RV values at 90o versus 0o transducer orientations for DDAI and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesion not shrinking by 25% or more over the course of chemotherapy.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo289.93 unitless ratioStandard Error 353.3
Biopsy Finding of MalignantWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo322.84 unitless ratioStandard Error 159.66
Biopsy Finding of BenignWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo332.70 unitless ratioStandard Error 241.89
Biopsy Finding of BenignWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo386.65 unitless ratioStandard Error 288.47
ARFI PD After Neoadjuvant Chemo 90 DegreesWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo144.27 unitless ratioStandard Error 115.12
ARFI PD After Neoadjuvant Chemo 90 DegreesWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo231.17 unitless ratioStandard Error 103.83
ARFI PD After Neoadjuvant Chemo 0 DegreeWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo191.86 unitless ratioStandard Error 100.15
ARFI PD After Neoadjuvant Chemo 0 DegreeWeighted Correlation Between Ratio of RV Values at 90o Versus 0o Transducer Orientations for DDAI to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo336.71 unitless ratioStandard Error 52.55
p-value: 0.34Regression, Linear
Primary

Weighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.

The ultrasound data will be processed to calculate relative elasticity (RE) and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Relative Elasticity (RE) - Qualitative estimate for tissue stiffness in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesion not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantWeighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo177.69 1/millimeterStandard Error 69.91
Biopsy Finding of MalignantWeighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo190.51 1/millimeterStandard Error 43.58
Biopsy Finding of BenignWeighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo89.41 1/millimeterStandard Error 87.51
Biopsy Finding of BenignWeighted Correlation Between Relative Elasticity (RE) to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo164.42 1/millimeterStandard Error 87.51
p-value: 0.42Regression, Linear
Primary

Weighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.

The ultrasound data will be processed to calculate relative viscosity (RV) and statistically correlated to response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Relative Viscosity (RV) - Qualitative estimate for tissue viscosity in the breast lesion based on VisR imaging. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantWeighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo384.55 milli second /millimeterStandard Error 207.7
Biopsy Finding of MalignantWeighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo362.58 milli second /millimeterStandard Error 179.51
Biopsy Finding of BenignWeighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo164.12 milli second /millimeterStandard Error 85.79
Biopsy Finding of BenignWeighted Correlation Between Relative Viscosity (RV) to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo281.54 milli second /millimeterStandard Error 100.05
p-value: 0.45Regression, Linear
Primary

Weighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.

The ultrasound data will be processed to calculate tissue mass (TM) for VisR and statistically correlated to the response of treatment with neoadjuvant chemotherapy. These values were weighted based on the number of imaging visits during subjects' treatment. Tissue Mass (TM) - Qualitative estimate for tissue mass in the breast lesion based on VisR imaging. Viscoelastic Response (VisR) - Ultrasound imaging technique in which a strong acoustic pulse is transmitted into the tissue, causing it to displace and recover. The tissue recovery curve is then fit to a mass-spring-damper physics model to estimate stiffness and viscosity. Response to chemo - Defined as the lesion shrinking by 25% or more over the course of chemotherapy. Non-responders to chemo - Defined as lesions not shrinking by 25% or more over the course of chemotherapy. Participants were imaged at baseline and end of each chemotherapy cycle. Patients were imaged 3-8 times w/ 3-4 weeks between scans.

Time frame: Up to 8 months

Population: Only women scheduled for neoadjuvant chemo and completed imaging (in total 4 subjects) were included in the analysis. One subject was withdrawn and was excluded from the analysis. Women scheduled for biopsy were not included.

ArmMeasureGroupValue (MEAN)Dispersion
Biopsy Finding of MalignantWeighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo0.02 Kg/mStandard Error 0.02
Biopsy Finding of MalignantWeighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo0.03 Kg/mStandard Error 0.01
Biopsy Finding of BenignWeighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.Responder to chemo0.05 Kg/mStandard Error 0.02
Biopsy Finding of BenignWeighted Correlation Between Tissue Mass (TM) for VisR to Predict Response to Neoadjuvant Chemotherapy.Non-responders to chemo0.05 Kg/mStandard Error 0.03
p-value: 0.18Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026