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Clinical Trial Summary

The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies.


Clinical Trial 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) or other prior imaging shows an indeterminate or suspicious 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03196076
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase Phase 2
Start date August 28, 2017
Completion date March 19, 2021

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