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Shear Wave Elastography in Native Kidney Disease

Primary Purpose

Acute Kidney Disease, Chronic Kidney Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shear wave elastography
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Disease focused on measuring kidney disease, fibrosis, ultrasound, elastography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Albert Einstein Healthcare Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shear wave elastography group

Arm Description

Patients referred for kidney biopsy will then undergo shear wave elastography measurements.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 7, 2016
Last Updated
May 19, 2020
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT02830438
Brief Title
Shear Wave Elastography in Native Kidney Disease
Official Title
Shear Wave Elastography in Native Kidney Disease: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants recruited
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
June 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Disease, Chronic Kidney Disease
Keywords
kidney disease, fibrosis, ultrasound, elastography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shear wave elastography group
Arm Type
Experimental
Arm Description
Patients referred for kidney biopsy will then undergo shear wave elastography measurements.
Intervention Type
Device
Intervention Name(s)
Shear wave elastography
Intervention Description
Ultrasound technique of the kidneys to assess wave elastography.
Primary Outcome Measure Information:
Title
Shear Wave Velocity of Kidney Parenchyma
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Naranjo-Tovar, MD
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25546304
Citation
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.
Results Reference
background
PubMed Identifier
26227484
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 Jul 31;16:119. doi: 10.1186/s12882-015-0120-7.
Results Reference
result
PubMed Identifier
26426636
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):e1590. doi: 10.1097/MD.0000000000001590.
Results Reference
result

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Shear Wave Elastography in Native Kidney Disease

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