Clinical Trial: Contrast-enhanced Ultrasound of the Kidney

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD (CEUS CKD)

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

Detailed Summary:

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.

Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Change in radiologist's lesion evaluation [ Time Frame: Baseline, 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: February 3, 2016
Date Started: February 2016
Date Completion: February 2018
Last Updated: May 15, 2017
Last Verified: May 2017