Contrast-enhanced Ultrasound of the Kidney
Condition: Chronic Kidney Disease; Cystic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Diseases, Cystic
Intervention: Perflutren lipid microsphere
Intervention description: Dosing per approved package label
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney
      malignancies
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for the present study, patients must meet the following criteria:

          1. Able to provide written informed consent

          2. Willing to comply with protocol requirements

          3. At least 18 years of age

          4. Have kidney disease, defined as either CKD II-VI, determined by estimated glomerular
             filtration rate (GFR) of <90 and derived from serum creatinine measurements, or
             albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to
             creatinine ratio of >30mg/gm, or having received a kidney transplant

          5. 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 an additional imaging tests.

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded for enrollment:

          1. 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)

          2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid
             (Definity®)

          3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure
             >90mmHg), or adult respiratory distress syndrome

          4. 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

          5. Is in an intensive care setting

          6. Has an unstable neurological disease (e.g cerebrovascular accident (including
             transient ischemic attacks (TIAs) within the 3 months before signing of informed
             consent

          7. Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery,
             nonsurgical cytoreductive procedure) since identification of lesion via US without
             contrast

          8. 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

          9. Female patient who is pregnant or lactating (the possibility of pregnancy has to be
             excluded by negative serum or urine beta human chorionic gonadotropin 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)

         10. Obesity that limits obtainment of acceptable images

             -