Shear Wave Elastography in Native Kidney Disease
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|ClinicalTrials.gov Identifier: NCT02830438|
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : January 15, 2019
In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples.
The overall goals of the proposed study are addressed by the following specific aim.
Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis.
Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Disease Chronic Kidney Disease||Device: Shear wave elastography||Not Applicable|
The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist.
A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist.
After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate.
The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Shear Wave Elastography in Native Kidney Disease: a Pilot Study|
|Actual Study Start Date :||July 1, 2016|
|Actual Primary Completion Date :||June 10, 2018|
|Actual Study Completion Date :||June 10, 2018|
Experimental: Shear wave elastography group
Patients referred for kidney biopsy will then undergo shear wave elastography measurements.
Device: Shear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.
- Shear wave velocity of kidney parenchyma [ Time Frame: 6 months ]The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula.
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): NCT02830438
|United States, Pennsylvania|
|Albert Einstein Healthcare Network|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Mario Naranjo-Tovar, MD||Albert Einstein Healthcare Network|