Shear Wave Elastography in Native Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Shear Wave Elastography in Native Kidney Disease: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02830438
• Other study ID #: 4837
• Secondary ID: 8574
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 10, 2018

Study information

• Verified date: May 2020
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 10, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Disease
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Shear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.

Locations

Country	Name	City	State
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hu Q, Wang XY, He HG, Wei HM, Kang LK, Qin GC. Acoustic radiation force impulse imaging for non-invasive assessment of renal histopathology in chronic kidney disease. PLoS One. 2014 Dec 29;9(12):e115051. doi: 10.1371/journal.pone.0115051. eCollection 2014. — View Citation

Lee J, Oh YT, Joo DJ, Ma BG, Lee AL, Lee JG, Song SH, Kim SU, Jung DC, Chung YE, Kim YS. Acoustic Radiation Force Impulse Measurement in Renal Transplantation: A Prospective, Longitudinal Study With Protocol Biopsies. Medicine (Baltimore). 2015 Sep;94(39) — View Citation

Samir AE, Allegretti AS, Zhu Q, Dhyani M, Anvari A, Sullivan DA, Trottier CA, Dougherty S, Williams WW, Babitt JL, Wenger J, Thadhani RI, Lin HY. Shear wave elastography in chronic kidney disease: a pilot experience in native kidneys. BMC Nephrol. 2015 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear Wave Velocity of Kidney Parenchyma	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. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome).	6 months