Contrast-enhanced Ultrasound of the Kidney (CEUS-CKD)
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|ClinicalTrials.gov Identifier: NCT02684435|
Recruitment Status : Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Cystic Kidney Disease||Drug: Perflutren lipid microsphere||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD (CEUS CKD)|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: 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
Drug: Perflutren lipid microsphere
Dosing per approved package label
- Change in radiologist's lesion evaluation [ Time Frame: Baseline, 1 year ]Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria to determine whether a lesion has progressed, regressed, or is stable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684435
|United States, North Carolina|
|University of North Carolina of Chapel hill|
|Chapel Hill, North Carolina, United States, 27599-7510|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Emily Chang, M.D.||University of North Carolina Kidney Center 7024 Burnett Womack CB #7155 Chapel Hill, NC 27599-7155|