Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: Perflutren lipid microsphere; Sulfur hexafluoride lipid microspheres
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal
      features of kidney lesions in patients with suspected kidney cancer with the same accuracy as
      conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)
    

Eligibility criteria:

        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