Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension

Inclusion Criteria

To be eligible for the present study, patients must meet the following criteria:

• Able to provide written informed consent
• Willing to comply with protocol requirements
• At least 18 years of age
• Have kidney disease, defined as either chronic kidney disease (CKD) II-V, determined by estimated glomerular filtration rate (GFR) of 30mg/gm within 3 months of recruitment, or on dialysis or having received a kidney transplant or have biopsy proven kidney disease. In these latter cases, blood and urine tests are not necessary.
• Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with additional imaging test(s).

Exclusion Criteria

Patients who meet any of the following criteria will be excluded for enrollment:

• Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
• Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
• Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), 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 14 days prior to the date of proposed Definity® administration
• Uncontrolled systemic hypertension (systolic blood pressure (BP)>180 mm Hg and/or diastolic BP>100 mm Hg despite optimal medical management)
• Is in an intensive care setting
• Has an unstable neurological disease (e.g., cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
• Has undergone an invasive procedure on kidney lesion (e.g., tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
• Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:
• Mental illness
• Drug abuse
• Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative point of care (POC), serum or urine beta-human chorionic gonadotropin (Β-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)
• Obesity that limits obtainment of acceptable images