Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD (CEUS CKD)
Overview
- Phase
- Phase 2
- Intervention
- Perflutren lipid microsphere
- Conditions
- Chronic Kidney Disease
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Specificity of Qualitative Interpretations of CEUS
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies
Detailed Description
This is an investigator-initiated, prospective study designed to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) with microbubble contrast agent (perflutren lipid; Definity®) to identify malignancy in patients with kidney disease, a known risk factor for kidney malignancy, in whom a conventional ultrasound (US) shows an indeterminate cystic kidney lesion. The primary objective of the study is to estimate the sensitivity of CEUS in diagnosing kidney malignancy in patients with a risk factor for kidney malignancy and compare it to the current gold standard test in this patient population. Secondary analysis will include more optimal contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in a subset of patients who can receive these studies. The study outcome will lead to immediate clinical application in patients with chronic kidney disease. Given the cost-effectiveness and adverse event profile, it has excellent potential to become established as first line diagnostics in the general patient population as well.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 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
- •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:
- •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
Arms & Interventions
Perflutren lipid microsphere
Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval
Intervention: Perflutren lipid microsphere
Outcomes
Primary Outcomes
Specificity of Qualitative Interpretations of CEUS
Time Frame: Baseline, 1 year
PRELIMINARY RESULTS of specificity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard
Number of Lesions With a Change in Radiologist's Evaluation
Time Frame: Baseline, 1 year
Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable.
Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy
Time Frame: Baseline, 1 year
PRELIMINARY RESULTS of sensitivity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard
Secondary Outcomes
- Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard(Baseline, 1 Year)
- Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard(Baseline, 1 Year)