Resolution Ultrasound Microvascular Imaging for Diagnosing Breast and Thyroid Cancer

Inclusion Criteria

• HEALTHY VOLUNTEERS: Adults >= 18 years old
• HEALTHY VOLUNTEERS: Able to provide informed consent
• HEALTHY VOLUNTEERS: Negative urine pregnancy test in women of child-bearing potential
• BREAST IMAGING PATIENTS: Women >= 18 years old
• BREAST IMAGING PATIENTS: Patient had a diagnostic breast ultrasound study performed at University of North Carolina (UNC)
• BREAST IMAGING PATIENTS: Scheduled for a core needle or surgical breast biopsy of at least one breast lesion that is 2 cm or less in size and 3 cm in depth from the skin surface
• BREAST IMAGING PATIENTS: Lesion visualized on ultrasound
• BREAST IMAGING PATIENTS: Able to provide informed consent
• BREAST IMAGING PATIENTS: Negative urine pregnancy test in women of child-bearing potential
• BREAST IMAGING PATIENTS: Breast Imaging Reporting and Data System (BIRADS) score of 4 or 5
• THYROID IMAGING PATIENTS: Adults >= 18 years old
• THYROID IMAGING PATIENTS: Patient had a diagnostic thyroid ultrasound study performed at UNC
• THYROID IMAGING PATIENTS: Thyroid Imaging Reporting and Data Systems (TIRADS) risk score of 4c or 5
• THYROID IMAGING PATIENTS: Scheduled for a core needle or surgical thyroid biopsy, fine needle aspiration, or thyroidectomy of at least one sonographically visible thyroid lesion that is 3 cm in depth from the skin surface
• THYROID IMAGING PATIENTS: Lesion visualized on ultrasound
• THYROID IMAGING PATIENTS: Able to provide informed consent
• THYROID IMAGING PATIENTS: Negative urine pregnancy test in women of child-bearing potential

Exclusion Criteria

• HEALTHY VOLUNTEERS: Institutionalized subject (prisoner or nursing home patient)
• HEALTHY VOLUNTEERS: Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease [COPD])
• HEALTHY VOLUNTEERS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity)
• HEALTHY VOLUNTEERS: 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). * Pulmonary hypertension * Cardiac shunts
• HEALTHY VOLUNTEERS: 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 (HCG) results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, as defined by the UNC Institutional Review Board [IRB] Standard Operating Procedure [SOP] 4801)
• BREAST IMAGING PATIENTS: 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)
• BREAST IMAGING PATIENTS: Institutionalized subject (prisoner or nursing home patient)
• BREAST IMAGING PATIENTS: Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease [COPD])
• BREAST IMAGING PATIENTS: Sonographically visible breast lesion larger than 2 cm or greater than 3 cm in depth from the skin surface
• BREAST IMAGING PATIENTS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity)
• BREAST IMAGING PATIENTS: 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) * Pulmonary hypertension * Cardiac shunts * 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)
• THYROID IMAGING PATIENTS: Institutionalized subject (prisoner or nursing home patient)
• THYROID IMAGING PATIENTS: Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease [COPD])
• THYROID IMAGING PATIENTS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity)
• THYROID IMAGING PATIENTS: 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) * Pulmonary hypertension * Cardiac shunts
• THYROID IMAGING PATIENTS: 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-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)