Contrast Enhanced Super Resolution Ultrasound Imaging to Improve Cancer Risk Assessment

Inclusion Criteria

• ARM 1 HEALTHY VOLUNTEERS: Adults ≥ 18 years old
• ARM 1 HEALTHY VOLUNTEERS: Able to provide informed consent
• ARM 1 HEALTHY VOLUNTEERS: Negative urine pregnancy test in women of child-bearing potential
• ARM 2 BREAST IMAGING PATIENTS: Women ≥ 18 years old
• ARM 2 BREAST IMAGING PATIENTS: Patient had a diagnostic breast ultrasound study performed at UNC
• ARM 2 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 4 cm or less in depth from the skin surface
• ARM 2 BREAST IMAGING PATIENTS: Lesion visualized on ultrasound
• ARM 2 BREAST IMAGING PATIENTS: Able to provide informed consent
• ARM 2 BREAST IMAGING PATIENTS: Negative urine pregnancy test in women of child-bearing potential
• ARM 2 BREAST IMAGING PATIENTS: Breast Imaging Reporting and Data System (BIRADS) score of 4 or 5
• ARM 3 KIDNEY IMAGING PATIENTS: Adults ≥ 18 years old
• ARM 3 KIDNEY IMAGING PATIENTS: Patient had a diagnostic renal ultrasound study performed at UNC
• ARM 3 KIDNEY IMAGING PATIENTS: Scheduled for a core needle or surgical renal biopsy (including nephrectomy) of at least one lesion that is 1cm or larger in size
• ARM 3 KIDNEY IMAGING PATIENTS: Lesion visualized on ultrasound
• ARM 3 KIDNEY IMAGING PATIENTS: Able to provide informed consent
• ARM 3 KIDNEY IMAGING PATIENTS: Negative urine pregnancy test in women of child-bearing potential
• ARM 4 LIVER IMAGING PATIENTS: Adults ≥ 18 years old
• ARM 4 LIVER IMAGING PATIENTS: Patient had a diagnostic liver ultrasound study performed at UNC
• ARM 4 LIVER IMAGING PATIENTS: Scheduled for a core needle or surgical liver biopsy of at least one lesion that is 1cm or larger in size
• ARM 4 LIVER IMAGING PATIENTS: Lesion visualized on ultrasound
• ARM 4 LIVER IMAGING PATIENTS: Able to provide informed consent
• ARM 4 LIVER IMAGING PATIENTS: Negative urine pregnancy test in women of child-bearing potential
• ARM 4 LIVER IMAGING PATIENTS: Liver Imaging Reporting and Data System (LI-RADS) score of 3 or higher

Exclusion Criteria

• ARM 1 HEALTHY VOLUNTEERS: Institutionalized subject (prisoner or nursing home patient)
• ARM 1 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])
• ARM 1 HEALTHY VOLUNTEERS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid microspheres (perflutren lipid [Definity®])
• ARM 1 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 * Pulmonary hypertension * Cardiac shunts
• ARM 1 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 [β-HCG] results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, as defined by the University of North Carolina [UNC] Institutional Review Board [IRB] Standard Operating Procedure [SOP] 4801.)
• ARM 2 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)
• ARM 2 BREAST IMAGING PATIENTS: Institutionalized subject (prisoner or nursing home patient)
• ARM 2 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])
• ARM 2 BREAST IMAGING PATIENTS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• ARM 2 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 * Pulmonary hypertension * Cardiac shunts
• ARM 2 BREAST 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 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.)
• ARM 3 KIDNEY IMAGING PATIENTS: Institutionalized subject (prisoner or nursing home patient)
• ARM 3 KIDNEY 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])
• ARM 3 KIDNEY IMAGING PATIENTS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• ARM 3 KIDNEY 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 * Pulmonary hypertension * Cardiac shunts
• ARM 3 KIDNEY 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 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.)
• ARM 4 LIVER IMAGING PATIENTS: Institutionalized subject (prisoner or nursing home patient)
• ARM 4 LIVER 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])
• ARM 4 LIVER IMAGING PATIENTS: Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• ARM 4 LIVER 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 * Pulmonary hypertension * Cardiac shunts
• ARM 4 LIVER 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 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.)