Acoustic Angiography and Ultrasound Imaging in Evaluating Patients with Breast Lesions

Inclusion Criteria

• Scheduled for breast core needle or surgical biopsy of at least one breast lesion based on suspicious breast lesion (Breast Imaging Reporting and Data System [BIRADS] score of 4 or 5) from pre-study standard of care (SOC) imaging studies
• Center of suspicious lesion is not deeper than 1.5 cm
• Able to provide informed consent
• Negative urine pregnancy test in women of child-bearing potential

Exclusion Criteria

• Institutionalized subject (prisoner or nursing home patient)
• Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease [COPD])
• Known hypersensitivity to any component of perflutren lipid (Definity)
• Right to left shunt, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), or adult respiratory distress syndrome
• 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 1 year prior to the date of proposed Definity administration * Uncontrolled systemic hypertension (systolic blood pressure [BP] > 150 mmHg and/or diastolic BP > 90 mmHg despite optimal medical management)
• 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 beta-human chorionic gonadotropin [beta-HCG] results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)