Academic-Industrial Partnership for Translation of Acoustic Angiography

Exclusion Criteria

• •1. Male (it is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents \<1% of newly diagnosed breast cancer)
• •2. Institutionalized subject (prisoner or nursing home patient)
• •3. Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
• •4. Sonographically visible breast lesion larger than 2cm or greater than 3cm in depth from the skin surface
• •5. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• •6. Active cardiac disease including any of the following:
• •* Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
• •* Unstable angina.
• •* Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
• •* Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
• •* Uncontrolled systemic hypertension (systolic blood pressure (BP) \>150 mm Hg and/or diastolic BP \>90 mm Hg despite optimal medical management).
• •7. Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history as defined by the UNC IRB SOP 4801 for child bearing potential)
• •Healthy Volunteers for Image Optimization
• •In addition to these clinical patients, 15 participants will be recruited to aid in optimizing the imaging parameters. These subjects must be willing to participate and able to provide written informed consent. However, these participants do not need to present any of the clinical indications as given for patients.