Chronic Kidney Disease Clinical Trial
Official title:
Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD (CEUS CKD)
The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies
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.
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