Study Results
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View full resultsBasic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2016-07-01
2018-06-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Shear wave elastography group
Patients referred for kidney biopsy will then undergo shear wave elastography measurements.
Shear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.
Interventions
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Shear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Albert Einstein Healthcare Network
OTHER
Responsible Party
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Mario Naranjo-Tovar, MD
Principal Investigator
Principal Investigators
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Mario Naranjo-Tovar, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein Healthcare Network
Locations
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Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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8574
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
4837
Identifier Type: -
Identifier Source: org_study_id
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