Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer

Study Overview
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Brief Summary
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This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue. SECONDARY OBJECTIVE: I. To determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results. OUTLINE: Patients undergo ultrasound without contrast. Patients then receive perflutren lipid microspheres (Definity) intravenously (IV) over 15 minutes and undergo CEUS.

Official Title
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Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Procedure: Ultrasonsgraphy
* Drug: Perflutren Lipid Microcpheres
* Procedure: Contrast - Enhanced Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent form Be conscious, willing and able to comply with all study procedures and be available for the duration of the study At least 21 years old Be scheduled for a breast biopsy (Breast Imaging Reporting and Data System [BIRAD] 4, 4A, 4B, 4C or 5) Patient with an at least 1 cm mass located at < 3 cm depth, approachable by 2.5 inch needle Be medically stable as determined by the investigator If a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of Definity Exclusion Criteria: Females who are pregnant or nursing Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example: Patients on life support or in a critical care unit Patients with unstable occlusive disease (e.g., crescendo angina) Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV) Patients with recent cerebral hemorrhage Patients who have undergone surgery within 24 hours prior to the study sonographic examination Patients with known hypersensitivity or allergy to any component of Definity Patients with unstable cardiopulmonary conditions or respiratory distress syndrome Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Ages Eligible for Study
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Minimum Age: 21 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)<br>Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS. | Procedure: Ultrasonsgraphy<br>* Undergo ultrasonography<br>* Other names: US;Drug: Perflutren Lipid Microcpheres<br>* Given IV<br>* Other names: Definity;Procedure: Contrast - Enhanced Ultrasound<br>* Undergo CEUS<br>* Other names: CEUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between subharmonic aided pressure estimation (SHAPE) results and direct measurements of interstitial fluid pressure (IFP) | Pearson's correlation coefficients will be computed between SHAPE results and direct IFP measurements by Stryker compartment pressure monitoring system. A Pearson's correlation coefficient above 0.5 will be considered a successful outcome. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of malignancy of breast tumor by the 3-dimensional subharmonic aided pressure estimation results | Generalized linear mixed logistic or generalized estimating equations logistic modeling of tumor versus non-tumor samples will be used to explore the potential for using SHAPE results as a novel functional predictor of breast tumor malignancy. Additionally, the subharmonic signal ratio from the tumor will be used to predict the malignancy of breast tumor using a biopsy result as a gold standard. The Mann-Whitney or Student's t-test will be performed depending on the distribution of the results. | At baseline |