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Trial record 33 of 7208 for:    "Kidney Diseases"

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

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.


Condition or disease Intervention/treatment Phase
Acute Kidney Disease Chronic Kidney Disease Device: Shear wave elastography Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Shear Wave Elastography in Native Kidney Disease: a Pilot Study
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Mario Naranjo-Tovar, MD 2154566500 naranjom@einstein.edu
Contact: Rachel Murphy 2154576159 murphyra@einstein.edu

Locations
United States, Pennsylvania
Albert Einstein Healthcare Network Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Mario Naranjo-Tovar, MD    215-456-6500    naranjom@einstein.edu   
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Mario Naranjo-Tovar, MD Albert Einstein Healthcare Network

Publications of Results:
Other Publications:
Responsible Party: Mario Naranjo-Tovar, MD, Principal Investigator, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02830438     History of Changes
Other Study ID Numbers: 4837
8574 ( Other Grant/Funding Number: Albert Einstein Society Grant )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Keywords provided by Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network:
kidney disease
fibrosis
ultrasound
elastography

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency