Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension
Completed · Phase 2
Conditions studied: Chronic Kidney Diseases, Cystic Kidney Disease
In brief
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies.
Key facts
- Study ID
- NCT03196076
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 25
- Starts
- 2017-08-28
- Expected to finish
- 2021-03-19
- Last updated by the study team
- 2021-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- To be eligible for the present study, patients must meet the following criteria:
- Able to provide written informed consent
- Willing to comply with protocol requirements
- At least 18 years of age
- 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.
- 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).
You may not qualify if…
- Patients who meet any of the following criteria will be excluded for enrollment:
- 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)
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
- Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome
- 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)
- Is in an intensive care setting
- Has an unstable neurological disease (e.g., cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
- Has undergone an invasive procedure on kidney lesion (e.g., tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
- 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
- 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)
- Obesity that limits obtainment of acceptable images
Where it is running
- University of North Carolina of Chapel hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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