Chronic Kidney Disease Clinical Trial
Official title:
Shear Wave Elastography in Native Kidney Disease: a Pilot Study
NCT number | NCT02830438 |
Other study ID # | 4837 |
Secondary ID | 8574 |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | June 10, 2018 |
Verified date | May 2020 |
Source | Albert Einstein Healthcare Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein Healthcare Network | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein Healthcare Network |
United States,
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
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 |
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