Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension
Condition: Chronic Kidney Diseases; Cystic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Diseases, Cystic
Intervention: Perflutren Lipid microsphere
Intervention description: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
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 chronic kidney disease (CKD) II-V, 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 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.

          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 additional imaging test(s).

        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 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)

         10. Obesity that limits obtainment of acceptable images