Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery

Study Overview
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Brief Summary
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This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.

Detailed Description
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PRIMARY OBJECTIVES: I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC). II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan). III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC. IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan). SECONDARY OBJECTIVES: I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response. II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables. OUTLINE: Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Official Title
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Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: dynamic contrast-enhanced ultrasound imaging
* Procedure: shear wave elastography
* Drug: Definity, (Lipid Microspheres) Intravenous Suspension
* Device: Philips Shear Wave Elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with histologically confirmed breast cancer (by core needle biopsy) Women with >= 2 cm clinically or radiologically measureable breast cancer Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan Women competent to sign study specific written Informed Consent Women willing to comply with protocol requirements Exclusion Criteria: Women who are pregnant Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis Women who have had a prior history of breast cancer in the same breast Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent Women who cannot consent for themselves

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CEUS, SWE)<br>Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery. | Procedure: dynamic contrast-enhanced ultrasound imaging<br>* Undergo CEUS<br>* Other names: DCE-USI;Procedure: shear wave elastography<br>* Undergo SWE<br>* Other names: SWE;Drug: Definity, (Lipid Microspheres) Intravenous Suspension<br>* Participant will receive contrast agent by intravenous administration<br>* Other names: Perflutren Lipid Microsphere;Device: Philips Shear Wave Elastography<br>* Equipment used for SWE<br>* Other names: Shear Wave Elastography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Model predicted treatment response for CEUS and SWE | Weighted Kappa will be used to assess the agreement. | Up to 1 year | 
| Pathologically determined treatment response for CEUS and SWE | Weighted Kappa will be used to assess the agreement. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response predicted by novel ultrasound techniques | Weighted Kappa will be used to assess the agreement. Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI. | Up to 1 year | 
| Treatment response predicted by CE MRI | Weighted Kappa will be used to assess the agreement. Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI. | Up to 1 year |