• Comparing diagnostic accuracy of F-R infusion imaging technique to low MI bolus imaging technique [ Time Frame: (Baseline) ]
  The model-building and evaluation strategy used for the primary objective will be used for bolus and infusion imaging modalities separately as well as in a combined multiparametric score. Standard errors will be obtained by bootstrapping correcting for the fact that both are derived from the same data and thus correlated.
• Predicting kidney mass stage using 3D CEUS-generated metrics [ Time Frame: (Baseline) ]
  The continuous variables WI and WO will be used to predict the binary measure of stage T3 or greater disease. We will calculate means (standard deviations) and 95% confidence intervals for WI and WO for those ≥ stage T3 vs. < stage T3, and compare via t-tests at alpha=.05. Logistic regression will be used to assess the abilities of WI and WO to predict stage T3 disease or greater, both separately and combined.

This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Eligible patients will include anyone who has suspected kidney cancer and is scheduled for surgery, up to an anticipated total of 40 participants. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.

Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.

• Drug: Perflutren lipid microsphere
  Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
  Other Names:

  • Definity
  • Microbubble contrast agent
• Drug: Sulfur hexafluoride lipid microspheres
  Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
  Other Name: Lumason

Inclusion Criteria:

• A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
• Able to provide informed consent
• Willing to comply with protocol requirements
• At least 18 years of age

Exclusion Criteria:

• Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable
• Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
• Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
• Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives

• Unstable cardiopulmonary 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
  • Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
  • Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
• Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, 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