Overview

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

Status:
Completed
Trial end date:
2021-03-19
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Lantheus Medical Imaging
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