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Shear Wave Elastography in Native Kidney Disease

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ClinicalTrials.gov Identifier: NCT02830438
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network

July 7, 2016
July 12, 2016
August 15, 2017
July 1, 2016
December 31, 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02830438 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Shear Wave Elastography in Native Kidney Disease
Shear Wave Elastography in Native Kidney Disease: a Pilot Study

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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Acute Kidney Disease
  • Chronic Kidney Disease
Device: Shear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.
Experimental: Shear wave elastography group
Patients referred for kidney biopsy will then undergo shear wave elastography measurements.
Intervention: Device: Shear wave elastography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
March 31, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients over 18 years of age who are referred for a native kidney biopsy.

Exclusion Criteria:

  • BMI > 35
  • Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal stones.
  • Patients who develop severe post biopsy complications (infection, significant bleeding requiring transfusion or intervention)
  • Pregnant patients.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Mario Naranjo-Tovar, MD 2154566500 naranjom@einstein.edu
Contact: Rachel Murphy 2154576159 murphyra@einstein.edu
United States
 
 
NCT02830438
4837
8574 ( Other Grant/Funding Number: Albert Einstein Society Grant )
No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
Not Provided
Principal Investigator: Mario Naranjo-Tovar, MD Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP