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

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

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.

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.

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